The Asthma and Allergy Foundation of America (AAFA) is sharing this press release from ALK to bring you the latest research news.

[PRESS RELEASE]

U.S. FDA Approves ALK's ODACTRA® (House Dust Mite Allergen Extract) Tablet for Sublingual Use as Immunotherapy for Adolescents

– ODACTRA is now indicated to treat house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis, in persons 12 through 17 years of age, in addition to adults 18 through 65 years of age –

– Nearly 50% of patients with allergies are sensitive to HDMs¹ –

ROUND ROCK, Texas, Jan. 25, 2023 -- ALK, a global, research-driven pharmaceutical company that focuses on the prevention, diagnosis and treatment of allergies, announced that the U.S. Food and Drug Administration (FDA) approved ODACTRA^® (House Dust Mite Allergen Extract) Tablet for Sublingual Use for the treatment of house dust mite (HDM)-induced allergic rhinitis in persons ages 12 through 17. ODACTRA was first launched for adults, ages 18 through 65, in the U.S. in 2017, and the expanded indication builds on ALK's treatment offerings for those suffering from allergies.

ODACTRA is an allergen extract indicated as immunotherapy for HDM-induced allergic rhinitis, with or without conjunctivitis, confirmed by in vitro testing for IgE antibodies to Dermatophagoides farinae or Dermatophagoides pteronyssinus HDMs, or skin testing to licensed HDM allergen extracts. ODACTRA is approved for use in persons 12 through 65 years of age. ODACTRA is not indicated for the immediate relief of allergic symptoms.² Please see Important Safety Information, including Boxed Warning, below.

"In many cases, for adolescents experiencing allergy symptoms throughout the year, house dust mites may be the underlying allergy trigger," said Michael Blaiss, MD, clinical professor of pediatrics, division of allergy/immunology at the Medical College of Georgia at Augusta University. "Allergies interfere with a critical time of adolescent development when they undergo physical, cognitive, emotional and social changes. ODACTRA sublingual immunotherapy treats house dust mite allergy and can even help those polysensitized patients manage their symptoms."

Data from several studies served as the basis for the expanded indication. The 28-day MT-18 trial was the first Phase 3 sublingual immunotherapy (SLIT)-tablet trial conducted only in adolescents. It evaluated the safety of ODACTRA in European adolescents aged 12 to 17 years (N=253) with HDM allergic rhinitis with/without conjunctivitis (AR/C), with or without mild asthma. The MT-18 trial's primary endpoint of at least one treatment-emergent adverse event (TEAE) was reported in 223 (88%) subjects and confirmed data from previously conducted North American and Japanese trials indicating that the HDM SLIT-tablet was well tolerated in adolescents with HDM AR/C.³

A post hoc analysis of two pooled, double-blind, placebo-controlled trials conducted in North America and Japan, adolescents aged 12 to 17 years (N=395) with HDM allergic rhinitis were randomized to up to one year of treatment.⁴ The study found that ODACTRA reduced the average total combined rhinitis score (TCRS), the study's primary endpoint, by 22% compared to placebo (treatment difference of −1.04; P<.01).⁴

The safety profile in children and adolescents was consistent with the safety profile in adults, and no treatment-related anaphylaxis, epinephrine administrations, severe local swellings, severe mouth or throat edema, or eosinophilic esophagitis occurred in the trials.³ The most common treatment-related adverse events (TRAEs) were local application site reactions.³ Most TRAEs were mild in intensity and were typically experienced the first one to two days of treatment.³

"We are proud to now offer ODACTRA, a convenient allergy immunotherapy tablet that can be taken at home following an initial administration visit with a healthcare provider experienced in diagnosing and treating allergies, to adolescents in the United States. ODACTRA is a flexible solution that offers the opportunity for relief as teens and parents navigate their overscheduled lives," said Hans Lindeberg, senior vice president of ALK North America. "This milestone underscores our commitment to continue to bring innovative solutions to the millions of people who suffer from chronic allergies, especially to adolescents during their critical development years."

What is ODACTRA?

ODACTRA is a prescription medicine used for sublingual (under the tongue) immunotherapy to treat house dust mite allergies that can cause sneezing, runny or itchy nose, stuffy or congested nose, or itchy and watery eyes. ODACTRA may be prescribed for persons 12 through 65 years of age who are allergic to house dust mites. ODACTRA is NOT a medication that gives immediate relief for symptoms of house dust mite allergy.²

Selected Important Safety Information about ODACTRA

What is the most important information I should know about ODACTRA?

• ODACTRA can cause severe allergic reactions that may be life-threatening. If any of these symptoms occur, stop taking ODACTRA and immediately seek medical care:
• • Trouble breathing
  • Throat tightness or swelling
  • Trouble swallowing or speaking
  • Dizziness or fainting
  • Rapid or weak heartbeat
  • Severe stomach cramps or pain, vomiting, or diarrhea
  • Severe flushing or itching of the skin
• For home administration of ODACTRA, your doctor should prescribe auto-injectable epinephrine, a medicine you can inject if you or your child have a severe allergic reaction after taking ODACTRA. Your doctor will train and instruct you on the proper use of auto-injectable epinephrine.
• If you forget to take ODACTRA, do not take two tablets. Take the next tablet at your normal scheduled time the next day. If you miss more than one tablet of ODACTRA, contact your doctor before restarting.
• Do not take ODACTRA if:
• • You have severe, unstable or uncontrolled asthma
  • You had a severe allergic reaction in the past that included any of these symptoms: trouble breathing, dizziness or fainting, rapid or weak heartbeat
  • You have ever had difficulty with breathing due to swelling of the throat or upper airway after using any sublingual immunotherapy before
  • You have ever been diagnosed with eosinophilic esophagitis
  • You are allergic to any of the inactive ingredients contained in ODACTRA. The inactive ingredients contained in ODACTRA are: gelatin, mannitol, and sodium hydroxide.
• Your doctor may decide that ODACTRA is not the best treatment if:
• • You have asthma, depending on how severe it is
  • You suffer from lung disease such as chronic obstructive pulmonary disease (COPD)
  • You suffer from heart disease such as coronary artery disease, an irregular heart rhythm, or you have hypertension that is not well controlled
  • You are pregnant, plan to become pregnant during the time you will be taking ODACTRA, or are breast-feeding
  • You are unable or unwilling to administer auto-injectable epinephrine to treat a severe allergic reaction to ODACTRA
  • You are taking certain medicines that enhance the likelihood of a severe reaction, or interfere with the treatment of a severe reaction. These medicines include:
  • • Beta blockers and alpha-blockers (prescribed for high blood pressure)
    • Cardiac glycosides (prescribed for heart failure or problems with heart rhythm)
    • Diuretics (prescribed for heart conditions and high blood pressure)
    • Ergot alkaloids (prescribed for migraine headache)
    • Monoamine oxidase inhibitors or tricyclic antidepressants (prescribed for depression)
    • Thyroid hormone (prescribed for low thyroid activity)
• If you are receiving allergy shots or other immunotherapy under the tongue. Use of more than one of these types of medicines together may increase the likelihood of a severe allergic reaction.
• Stop taking ODACTRA and contact your doctor if you have any mouth surgery procedures (such as tooth removal), develop any mouth infections, ulcers or cuts in the mouth or throat, or have heartburn, difficulty swallowing, pain with swallowing, chest pain that does not go away or worsens, asthma or any other breathing condition that worsens, or any type of serious allergic reaction.
• The most commonly reported side effects were throat irritation/tickle, itching in the mouth or ears, swelling of the back of the mouth, lips or tongue, tongue pain, nausea, throat swelling, stomach pain, tongue ulcer/sore on the tongue, and mouth ulcer/sore in the mouth, diarrhea, and food tastes different. These side effects, by themselves, were not dangerous or life-threatening. Typically, these common side effects begin within the first week of starting ODACTRA and may reoccur for up to two weeks. These common side effects experienced after taking the first tablet typically last up to one hour.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information, including Boxed WARNING and Medication Guide, for additional Important Safety Information.

About ALK

ALK is a global, research-driven pharmaceutical company that focuses on the prevention, diagnosis and treatment of allergies. It markets allergy immunotherapy treatments and other products and services for people with allergy and allergy doctors. Headquartered in Hørsholm, Denmark, ALK employs around 2,600 people worldwide and is listed on Nasdaq Copenhagen. Find more information at www.alk.net.

For further information, please contact:
Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile +45 2261 2525
Media: Dan Commerford, tel. +1 908 842 8355

References

¹ Bauchau V. Prevalence and rate of diagnosis of allergic rhinitis in Europe. European Respiratory Journal. 2004;(5):758-764. doi:10.1183/09031936.04.00013904.
² ODACTRA. Prescribing information. ALK-Abelló, Inc.; Rev. 2023.
³ Horn A, Bernstein DI, Okubo K, et al. Safety of house dust mite sublingual immunotherapy tablet in adolescents with allergic rhinoconjunctivitis: clinical trial results. JACI. 2022.
⁴ Matsuoka T, Bernstein DI, Masuyama K, et al. Pooled efficacy and safety data for house dust mite sublingual immunotherapy tablets in adolescents. Pediatr Allergy Immunol. 2017;28(7):661-667. doi:10.1111/pai.12747.

SOURCE ALK, INC.

Flowers, candy, perfume, and candles may be popular gifts for many occasions. But if you give them to someone you know with asthma and allergies, you may give them something you didn’t plan on – triggers that cause symptoms.

Instead, give non-traditional gifts to people who have asthma or allergies. They will appreciate your efforts. And you will help them avoid an allergic reaction or an asthma episode. Use this as a chance to give creative asthma and allergy friendly gifts they won’t forget.

Consider the following when giving gifts to people with asthma and allergies.

Choose Gifts Free of Pollen and Scents

Flowers and plants can carry pollen or mold. They can cause allergy symptoms or trigger allergic asthma.

Some items have strong scents that can irritate the airways of a person with asthma:

• Perfume and cologne
• Wax candles and potpourri
• Scented personal care products
• Some flowers
  
  

Give homemade cards, special notes, gift cards, homemade “coupon” books, LED candles, or photos. Plan a fun night out.

If you’re thinking about a cozy evening at home, don’t light the fireplace or fire pit. Smoke of any type can trigger asthma symptoms. Use a blanket instead for a smoke-free night.

Give Items That Won’t Irritate Their Skin

If you give to someone who has skin allergies, avoid gifts that contain nickel, such as nickel-plated jewelry. Also, be careful with personal care items like scented lotions and shower gels. These items can trigger symptoms for some people with skin allergies like atopic dermatitis (eczema).

Watch for Food Allergens in Meals and Candy

Does your gift recipient have a food allergy? If you are considering a food gift, talk to them first. Learn how to read labels. For example, many chocolates come in contact with common allergens like nuts and dairy during manufacturing.

Not all restaurants handle food allergies the same way. Restaurants can be busier on holidays and weekends, so there’s a higher chance of mix-ups in the kitchen. Try a creative food-free experience instead. Or make a safe meal together at home.

Give Them a Healthier Home

Cleaning can expose people to dust mites or mold. Improve someone’s indoor air quality by cleaning for them. Focus on places where allergens and asthma triggers like to hide the most. These are bedrooms, living rooms, and kitchens. And don’t forget the bathrooms where mold loves to grow. You could even give a CERTIFIED asthma & allergy friendly® product. They are scientifically tested to make sure they create a healthier home.

Honor Them by Helping Others

Managing asthma and allergies can have a great impact on a person’s well-being and quality of life. Give a donation in their honor to the Asthma and Allergy Foundation of America (AAFA). Your donation can help educate, advocate for and support people with asthma and allergies. Supporting people also facing these conditions is a great way to show you care.

The Asthma and Allergy Foundation of America (AAFA) is sharing this press release from Sanofi to bring you the latest research news.

[PRESS RELEASE]

FDA accepts nirsevimab application as first protective option against RSV disease for all infants

FDA accepts nirsevimab application as first protective option against RSV disease for all infants

• Nirsevimab would be the first broadly protective option against RSV disease designed for all infants, if approved
• Nirsevimab delivered consistent protection of approximately 80% against medically attended RSV disease across several trials in healthy term and preterm infants and has been approved under accelerated review in the EU and the UK
  
  

Paris, January 5, 2023. The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has accepted the Biologics License Application (BLA) for nirsevimab for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants entering or during their first RSV season and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

Nirsevimab is being developed jointly by Sanofi and AstraZeneca and, if approved, would be the first protective option for the broad infant population, including those born healthy, at term or preterm, or with specific health conditions. The FDA has indicated they will work to expedite their review. The Prescription Drug User Fee Act date, the FDA target action date for their decision, is in the third quarter of 2023.

Thomas Triomphe
Executive Vice President, Vaccines, Sanofi
“This is a landmark file acceptance in the US as it brings us one step closer to offering the first and only broadly protective option against RSV disease designed for all infants. Given the unprecedented number of otherwise healthy infants who have been hospitalized with RSV this year in the US and the recurrent pattern of RSV epidemics year after year, it is our intention to make nirsevimab available, if approved in time, for the 2023/2024 season to help alleviate the burden of RSV on families and the healthcare system.”

RSV is a very contagious virus that can lead to serious respiratory illness, according to the Centers for Disease Control and Prevention (CDC).10 In the US, RSV is the leading cause of hospitalisation for babies under one.11 Any infant can be hospitalized in their first RSV season: about 75% of infants hospitalized for RSV in the U.S. are born at term, with no underlying conditions.^12-14 The current 2022/23 RSV season has placed a particularly high burden on infants and families in the United Stated with the American Academy of Pediatrics (AAP) requesting the White House declare an emergency to support the national response to the alarming surge of pediatric hospitalizations due to RSV and influenza.

Dr William Muller
Associate Professor, Pediatrics, Northwestern University Feinberg School of Medicine and Scientific Director, Clinical and Community Trials, Ann & Robert H. Lurie Children’s Hospital of Chicago, Illinois
"A substantial burden of disease from RSV affects infants, families, and healthcare providers every year. Effective interventions to prevent RSV are a critical need. This year in the US, we’ve seen first-hand how frightening the impact of this respiratory disease is on our patients and how stressful it is on the healthcare system, highlighting the urgency of addressing this problem."

The submission was based on results from the Phase 3 MELODY, Phase 2/3 MEDLEY and Phase 2b trials.^1-8 Results across the MELODY and Phase 2b trials showed that nirsevimab demonstrated consistent protection of approximately 80%, against medically attended RSV disease with a single dose.^1-5

In these trials, nirsevimab helped protect an all-infant population (including healthy term, late preterm, and preterm infants, as well as infants with specific health conditions) against RSV disease requiring medical care, including physician office, urgent care, emergency room visits and hospitalizations, through the duration of the RSV season.1-8 The safety profile of nirsevimab was similar to placebo. Nirsevimab also demonstrated a comparable safety and tolerability profile to palivizumab in the Phase 2/3 MEDLEY trial.^7-9

About nirsevimab

In the U.S., nirsevimab is an investigational single-dose long-acting antibody designed to help protect all infants from birth through their first RSV season and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

Nirsevimab has been developed to offer newborns and infants direct RSV protection via an antibody to help prevent lower respiratory tract infection (LRTI) caused by RSV. Monoclonal antibodies do not require the activation of the immune system to help offer timely, rapid and direct protection against disease.¹⁵

In March 2017, Sanofi and AstraZeneca announced an agreement to develop and commercialize nirsevimab. Under the terms of the agreement, AstraZeneca leads all development and manufacturing activities and Sanofi leads commercialization activities and records revenues. Under the terms of the global agreement, Sanofi made an upfront payment of €120m, has paid a development milestone of €30m and will pay up to a further €465m upon achievement of certain development and sales-related milestones. The two companies share all costs and profits.

Nirsevimab has been granted designations to facilitate expedited development by several regulatory agencies around the world. These include Breakthrough Therapy Designation by the China Center for Drug Evaluation under the National Medical Products Administration; Breakthrough Therapy Designation from the FDA; access granted to the European Medicines Agency (EMA) PRIority MEdicines scheme; Promising Innovative Medicine designation by the UK Medicines and Healthcare products Regulatory Agency; and named “a medicine for prioritized development” under the Project for Drug Selection to Promote New Drug Development in Pediatrics by the Japan Agency for Medical Research and Development (AMED). Nirsevimab was approved by the European Commission in October 2022, and by the UK Medicines and Healthcare products Regulatory Agency (MHRA) in November 2022.^16,17

About the clinical trials

The Phase 2b trial was a randomized, placebo-controlled trial designed to measure the efficacy of nirsevimab against medically attended LRTI through 150 days post-dose. Healthy preterm infants of 29–<35 weeks’ gestation (n= 1,453) were randomized (2:1) to receive a single 50mg intramuscular injection of nirsevimab (n= 969) or placebo (n= 484) at the RSV season start.^3,4 The primary endpoint was met, significantly reducing the incidence of medically attended LRTI caused by RSV by 70.1% (95% CI: 52.3, 81.2) compared to placebo.^3,4 The proposed dosing regimen was recommended based on further exploration of the Phase 2b data.³ When considering the dosing regimen recommended for approval in this study, nirsevimab reduced the incidence of medically attended LRTI caused by RSV by 86.2% (95% CI: 68.0, 94.0) in gestational age ≥29 to <35 weeks.^3,4 The subsequent Phase 3 study, MELODY, applied the recommended dosing regimen.^1,2

The Phase 3 MELODY (primary cohort) trial was a randomized, placebo-controlled trial conducted across 21 countries designed to determine efficacy of nirsevimab against medically attended LRTI due to RSV confirmed by reverse transcriptase polymerase chain reaction testing through 150 days after dosing, versus placebo, in healthy late preterm and term infants (35 weeks gestational age or greater) entering their first RSV season.^1,2 The primary endpoint was met, significantly reducing the incidence of medically attended LRTI, such as bronchiolitis or pneumonia, caused by RSV compared to placebo.^1,2 Infants were randomized (2:1) to receive a single 50mg (in infants weighing <5kg) or 100mg (in infants weighing ≥5kg) intramuscular injection of nirsevimab or placebo.^1,2

Following the analysis of the initial 1,490 infants within the MELODY primary cohort additional infants continued to be enrolled. A total of 3,012 healthy late preterm and term infants (35 weeks gestational age or greater) entering their first RSV season were randomized to receive nirsevimab (n=2,009) or placebo (n=1,003). In the exploratory analysis, a single 50mg (in infants weighing <5kg) or 100mg (in infants weighing ≥5kg) intramuscular injection of nirsevimab reduced the incidence of medically attended LRTI caused by RSV through 150 days after dosing by 76.4% (95%: CI 62.3, 85.2) compared to placebo, with an acceptable safety profile. Further, nirsevimab demonstrated a 76.8% (95%: CI 49.4, 89.4) reduction in the risk of RSV LRTI with hospitalization through 150 days after dosing compared to placebo.

MEDLEY was a Phase 2/3, randomized, double-blind, palivizumab-controlled trial with the primary objective of assessing safety and tolerability for nirsevimab in preterm infants and infants with congenital heart disease (CHD) and/or chronic lung disease of prematurity (CLD) eligible to receive palivizumab.^7,8 Between July 2019 and May 2021, approximately 918 infants entering their first RSV season were randomized to receive a single 50mg (in infants weighing <5kg) or 100mg (in infants weighing ≥5kg) intramuscular injection of nirsevimab or palivizumab. Safety was assessed by monitoring the occurrence of treatment emergent adverse events (TEAEs) and treatment emergent severe adverse events (TESAEs) through 360 days post-dose.7,8 Serum levels of nirsevimab following dosing (on day 151) in this trial were comparable with those observed in the Phase 3 MELODY trial, indicating similar protection in this population to that in the healthy term and late preterm infants is likely.⁷

The safety profile of nirsevimab was similar to palivizumab in the MEDLEY Phase 2/3 and consistent with the safety profile in term and preterm infants studied in the MELODY Phase 3 trial compared to placebo.1-4,7,8 The most commonly reported adverse reactions were: rash 14 days post-dose, (the majority of which were mild to moderate); pyrexia (fever) within 7 days post-dose; non-serious injection site reactions within 7 days post-dose.¹⁶

Findings from the nirsevimab clinical trial program included a pre-specified pooled analysis of the Phase 3 MELODY trial (primary cohort) and the recommended dose from the Phase 2b trial, in which a relative risk reduction of 79.5% versus placebo (95% CI 65.9, 87.7; P<0.0001) was seen against medically attended LRTI, such as bronchiolitis or pneumonia, caused by RSV in infants born at term or preterm entering their first RSV season.5 This analysis also showed a relative risk reduction of 77.3% (95% CI 50.3, 89.7; P<0.001) against RSV LRTI hospitalizations.⁵

About RSV

RSV is a very contagious virus that can lead to serious respiratory illness for infants, according to the Centers for Disease Control and Prevention (CDC).¹⁰ In the U.S., RSV is the leading cause of hospitalization in infants under 12 months.¹¹ Approximately 75% of infants hospitalized for RSV are born at term with no underlying conditions.^12-14 RSV symptoms can include runny nose, coughing, sneezing, fever, decrease in appetite, and wheezing.¹⁰ Each year RSV infection leads to approximately 500,000 emergency department visits by children under 5 years of age, which represents 1 in 4 of all RSV-related doctor visits, according to the CDC.¹⁸

About Sanofi
We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.

Media Relations
Sandrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.com
Sally Bain | + 1 617 834 6026 | sally.bain@sanofi.com
Evan Berland | + 1 215 432 0234 | evan.berland@sanofi.com
Kate Conway | + 1 508 364 4931 | kate.conway@sanofi.com

References
1. Hammitt LL, MD et al. Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants. N Engl J Med. 2022;386 (9): 837-846. doi: 10.1056/NEJMoa2110275.
2. Clinicaltrials.gov. A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Late Preterm and Term Infants (MELODY). https://clinicaltrials.gov/ct2/show/NCT03979313. Accessed December 2022.
3. Clinicaltrials.gov. A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants. (MEDI8897 Ph2b). https://clinicaltrials.gov/ct2.../results/NCT02878330. Accessed December 2022.
4. Griffin P, MD et al. (2020). Single-Dose Nirsevimab for Prevention of RSV in Preterm Infants. NEJM 2020; 383: 415-425. DOI: 10.1056/NEJMoa1913556.
5. Simões, E, et al. Pooled efficacy of nirsevimab against RSV lower respiratory tract infection in preterm and term infants. ESPID 2022 Congress; 2022 May 9-13. Hybrid Congress.
6. Wilkins, D, et al. Nirsevimab for the prevention of respiratory syncytial virus infection: neutralizing antibody levels following a single dose. ESPID 2022 Congress; 2022 May 9-13. Hybrid Congress.
7. Domachowske J, MD et al. Safety of Nirsevimab for RSV in Infants with Heart or Lung Disease or Prematurity. N Engl J Med. 2022; 386 (9).
8. Clinicaltrials.gov. A Study to Evaluate the Safety of MEDI8897 for the Prevention of Medically Attended Respiratory Syncytial Virus (RSV) Lower Respiratory Track Infection (LRTI) in High-risk Children. https://clinicaltrials.gov/ct2/show/NCT03959488 (MEDLEY). Accessed December 2022.
9. Synagis - Summary of Product Characteristics (SmPC) - (eMC) [Internet]. Available from: https://www.ema.europa.eu/en/d...t-information_en.pdf Accessed December 2022.
10. Centers for Disease Control and Prevention. RSV in Infants and Young Children. Centers for Disease Control and Prevention. December 18, 2020. https://www.cdc.gov/rsv/high-r...-young-children.html Accessed December 2022.
11. Leader S, Kohlhase K. Recent trends in severe respiratory syncytial virus (RSV) among US infants, 1997 to 2000. J Pediatr. 2003;143(5 Suppl):S127-S132. doi:10.1067/s0022-3476(03)00510-9.
12. Arriola CS, Kim L, Langley G, et al. Estimated burden of community-onset respiratory virus–associated hospitalizations among children aged <2 years in the United States, 2014-15. J Pediatric Infect Dis Soc. 2020;9(5):587-595.
13. Hall, C. B. et al. Respiratory syncytial virus-associated hospitalizations among children less than 24 months of age. Pediatrics 132, e341-8 (2013).
14. Gantenberg, J. R. et al. Medically Attended Illness due to Respiratory Syncytial Virus Infection Among Infants Born in the United States Between 2016 and 2020.
15. Centers for Disease Control and Prevention. Vaccines & Immunizations. August 18, 2017. https://www.cdc.gov/vaccines/v...n/immunity-types.htm. Accessed December 2022.
16. European Commission. https://www.ema.europa.eu/en/d...t-information_en.pdf. Accessed December 2022.
17. Medicines & Healthcare products Regulatory Agency. https://assets.publishing.serv...14_November_2022.pdf. Accessed December 2022.
18. Hall, C. B. et al. The burden of respiratory syncytial virus infection in young children. New Engl J Medicine 360, 588–98 (2009)

The Asthma and Allergy Foundation of America (AAFA) recently announced our new website. We updated the look of our food allergy division, Kids with Food Allergies (KFA), too!

Through KFA, it is our mission to save lives and reduce the burden of food allergies through support, advocacy, education, and research. We have redesigned the KFA logo, our website, and our Safe Eats® Allergy-Friendly Recipe Collection to better help families manage their children’s food allergies with confidence.

We redesigned the KFA website to improve accessibility and support for people managing food allergies. Here are some of the changes you may notice:

• An updated design
• A new logo
• Easier-to-read text
• Streamlined menu navigation
• Improved search function
  
  

Children are at the heart of our work, and food allergies affect children of all populations and ages. We worked with Farida Zaman, an artist who specializes in children’s book illustrations, to create fun and diverse representations of children of various ages and cultures that we have incorporated into our new brand.

Members of the KFA online community will also notice a new look, including:

• Streamlined menu navigation – all content including forum topics, blogs, and surveys will be under one menu item titled “Posts”
• New subgroups will be easier to find and join
• A weekly “What’s New” digest email with a personalized summary of trending posts, upcoming events, and content by people you follow (watch for more information soon on how you can change your notifications)
  
  

Our goal is that the new kidswithfoodallergies.org will be a lively and inclusive hub for expanding the awareness and understanding of food allergies. KFA's website offers:

• Evidence-based information to help people manage food allergies
• A free, online support community to connect with other people who live with food allergies
• Updates about KFA’s projects, research, and advocacy efforts
• Resources for stakeholders, such as health care providers, community health organizations, and advocates, seeking to improve health outcomes
  
  

Check out the new kidswithfoodallergies.org. Along with AAFA’s new site, KFA’s new brand is another step in our efforts to serve as a vital lifeline to people managing asthma and allergies.

When spring allergy season first starts, causing you to sniffle and sneeze, tree pollen is to blame. Trees start producing pollen as early as January in the Southern U.S. Many trees keep producing pollen through May.

What Are the Symptoms of a Tree Pollen Allergy?

Pollen allergy symptoms are commonly called “hay fever.” Pollen released by trees, as well as grasses and weeds, cause these symptoms. They include:

• Runny nose (also known as rhinorrhea – this is typically a clear, thin nasal discharge)
• Stuffy nose (due to blockage or nasal congestion – one of the most common and troublesome symptoms)
• Sneezing
• Itchy nose, eyes, ears, and mouth
• Red and watery eyes
• Swelling around the eyes
  
  

If you have allergic asthma and are allergic to tree pollen, you might also have asthma symptoms while the trees are pollinating.

Tree pollen is light so the wind can carry it for miles. These light, dry grains easily find their way to your sinuses, lungs, and eyes, making them hard to avoid.

What Trees Cause the Most Symptoms?

Some tree pollen causes more problems than others. Some of the trees that cause the most symptoms are:

• Alder
• Ash
• Aspen
• Beech
• Birch
• Box elder
• Cedar
• Cottonwood
• Elm
• Hickory
• Juniper
• Maple
• Mulberry
• Oak
• Olive
• Pecan
• Poplar
• Walnut
• Willow
  
  

Being allergic to some trees could cause you to react to certain foods. It happens because the tree pollen is similar to the protein in some fruits, vegetables, and nuts.¹ Your immune system gets confused and can’t tell the difference between the two. Eating these foods may cause your mouth or face to itch or swell. These foods may include apples, cherries, pears, and more. This is called pollen food allergy syndrome (PFAS) or oral allergy syndrome (OAS). Birch and alder trees cause the most PFAS food reactions.

In some cases, your tree pollen allergy may cross-react with some nuts, like peanuts or almonds. If you have mouth itching or swelling while eating nuts, you could have a more serious, life-threatening reaction called anaphylaxis, which is common with nut allergies. If this happens to you, call your doctor right away.

What Can I Do to Relieve My Pollen Allergy Symptoms?

Thankfully, there are several options for relieving pollen allergy symptoms, available both over the counter and by prescription. Talk with your doctor about your symptoms and treatment options. Your doctor might have you take a combination of medicines to keep your symptoms controlled. These medicines include:

• Nasal sprays
• Eye drops
• Antihistamines
• Decongestants
• Leukotriene [loo-kuh-trahy-een] modifiers (such as montelukast)
  
  

If these medicines don’t completely relieve your symptoms, your doctor might also give you immunotherapy. This is a long-term treatment that can reduce the severity of your allergic reactions. It usually involves regular shots, tablets, or drops you take under the tongue.

You can also take steps to reduce your exposure to tree pollen:

• If you haven’t had allergy testing, find a board-certified allergist to test you for pollen allergies. Work with your doctor to come up with a treatment plan.
  
  
• Start taking allergy medicine before pollen season begins.
  
  

• Limit your outdoor activities when pollen counts are high. This will cut down the amount of pollen allergen you inhale and help reduce your symptoms.
  
  

• Watch pollen counts on a website like the National Allergy Bureau™.
  
  
• Wear sunglasses and cover your hair when going outside.
  
  
• Keep your windows closed during peak tree pollen season and use a CERTIFIED asthma & allergy friendly® filter on your central air conditioner.
  
  
• Wipe your pets off before they come indoors.
  
  
• Dry your clothes in a dryer and not outside on a clothesline.
  
  
• Change and wash clothes you wear during outdoor activities as soon as you come inside.
  
  

It may be hard to avoid tree pollen during the late winter and spring. But you can reduce your symptoms with the right treatment.

Medical Review: Content summarized from https://aafa.org/allergies/typ...tree-pollen-allergy/ which was reviewed June 2022 by John James, MD

References
1. Oral allergy syndrome (OAS) | AAAAI. (n.d.). Retrieved January 17, 2023, from https://www.aaaai.org/tools-fo...lergy-syndrome-(oas)

The Asthma and Allergy Foundation of America (AAFA) is sharing this press release from AstraZeneca to bring you the latest research news.

AAFA had the opportunity to recruit participants for the MANDALA and DENALI clinical trials mentioned below. Thank you to our members who volunteered to be part of this research that helped make another FDA-approved asthma treatment possible.

[PRESS RELEASE]

AIRSUPRA (PT027) approved in the US for asthma

AIRSUPRA^TM (albuterol/budesonide), formerly known as PT027, has been approved in the US for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in people with asthma aged 18 years and older.

The approval by the Food and Drug Administration (FDA) was based on results from the MANDALA and DENALI Phase III trials.^1,2 In MANDALA, AIRSUPRA significantly reduced the risk of severe exacerbations compared to albuterol in patients with moderate to severe asthma when used as an as-needed rescue medication in response to symptoms.¹ Importantly, in the secondary endpoint of mean annualized total systemic corticosteroid exposure, AIRSUPRA demonstrated a significant reduction compared to albuterol at the approved dose of 180mcg albuterol/160mcg budesonide.¹ In DENALI, AIRSUPRA significantly improved lung function compared to the individual components albuterol and budesonide in patients with mild to moderate asthma.²

AIRSUPRA is a first-in-class, pressurized metered-dose inhaler (pMDI), fixed-dose combination rescue medication containing albuterol, a short-acting beta2-agonist (SABA), and budesonide, an anti-inflammatory inhaled corticosteroid (ICS) in the US. It is being developed by AstraZeneca and Avillion.

Bradley E. Chipps, Past President of the American College of Allergy, Asthma & Immunology and Medical Director of Capital Allergy & Respiratory Disease Center in Sacramento, US, said: “People with asthma are at risk of severe exacerbations regardless of their disease severity or level of control. Current albuterol rescue inhalers alleviate acute symptoms, but do not treat the underlying inflammation in asthma. The approval of AIRSUPRA means that for the first time, adults with asthma in the US have a rescue treatment to manage both their symptoms and the inflammatory nature of their disease.”

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: “With patients experiencing more than 10 million asthma exacerbations each year in the US and uncontrolled asthma expected to cost the US economy billions of dollars in direct medical costs alone over the next 20 years, today’s positive decision is good news for those adults with asthma who make up more than 80% of asthma patients in the US. Physicians will be able to offer their patients AIRSUPRA, an important new rescue treatment that reduces the risk of asthma exacerbations.”

Asthma is a chronic, inflammatory respiratory disease with variable symptoms that affects as many as 262 million people worldwide.³ In the US over 21 million adults have asthma, representing more than 80% of the total number of people with asthma.⁴ Adults have 8.5 million exacerbations each year in the US.⁴ Uncontrolled asthma will cost the US economy an estimated $300 billion (in 2018 dollar values) in the next 20 years in direct medical costs alone.⁵

The safety and tolerability of AIRSUPRA in both trials were consistent with the known profiles of the components,^1,2 with the most common adverse events including headache, oral candidiasis, cough and dysphonia.⁶

Results from the MANDALA trial were published in the New England Journal of Medicine in May 2022.¹

INDICATION

AIRSUPRA is a combination of albuterol, a beta₂-adrenergic agonist and budesonide, a corticosteroid, indicated for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in patients with asthma 18 years of age and older.

Please see full Prescribing Information, including Patient Information.

AIRSUPRA

AIRSUPRA (albuterol/budesonide), formerly known as PT027, is a first-in-class SABA/ICS rescue treatment for asthma in the US, to be taken as needed. It is an inhaled, fixed-dose combination rescue medication containing albuterol (also known as salbutamol), a SABA, and budesonide, a corticosteroid, and has been developed in a pMDI using AstraZeneca’s Aerosphere delivery technology.

AstraZeneca and Avillion collaboration

In March 2018, AstraZeneca and Avillion signed an agreement to advance AIRSUPRA through a global clinical development program for the treatment of asthma. Under the terms of the agreement, Avillion became the trial sponsor responsible for executing and funding the multicenter, global clinical trial program for AIRSUPRA through NDA filing to a regulatory decision in the US. Following the successful approval of AIRSUPRA, AstraZeneca has the option, upon certain financial payments, to commercialize the medicine in the US.

AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines in Oncology, Rare Diseases and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries, and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca-us.com and follow us on Twitter @AstraZenecaUS.

Media Inquiries

Brendan McEvoy          +1 302 885 2677
Jillian Gonzales                      +1 302 885 2677

US Media Mailbox: usmediateam@astrazeneca.com

References

1. Papi A, et al. Albuterol–Budesonide Fixed-Dose Combination Rescue Inhaler for Asthma. N Engl J Med2022; 386 (22): 2071-2083.
2. Chipps BE, et al. Efficacy and safety of albuterol/budesonide (PT027) in mild-to-moderate asthma: Results of the DENALI study. Am J Respir Crit Care Med2022; 205: A3414. Abstract. Available at: https://doi.org/10.1164/ajrccm...etingAbstracts.A3414 [Last accessed: November 2022].
3. The Global Asthma Network. The Global Asthma Report 2022. [Online]. Available at: http://globalasthmareport.org/index.html[Last accessed: November 2022].
4. CDC. Most Recent National Asthma Data. [Online]/ Available at: https://www.cdc.gov/asthma/mos...onal_asthma_data.htm. [Last accessed: November 2022].
5. Yaghoubi M, et al. The Projected Economic and Health Burden of Uncontrolled Asthma in the United States. Am J Respir Crit Care Med. 2019; 200 (9): 1102-1112.
6. Airsupra(albuterol/budesonide) US prescribing information; 2023.
7. Global Initiative for Asthma. Global strategy for asthma management and prevention, 2022. Available at: https://ginasthma.org/wp-conte...NAL-22-07-01-WMS.pdf. [Last accessed: November 2022].
8. Price D, et al. Asthma control and management in 8,000 European patients: the REcognise Asthma and LInk to Symptoms and Experience (REALISE) survey. NPJ Prim Care Respir Med. 2014; 24: 14009.
9. Papi A, et al. Relationship of inhaled corticosteroid adherence to asthma exacerbations in patients with moderate-to-severe asthma. J Allergy Clin Immunol Pract. 2018; 6 (6): 1989-98.e3.
10. AstraZeneca Pharmaceuticals. Data on File. Budesonide/formoterol Data on File: Annual Rate of Asthma Exacerbations Globally. (REF-173201)
11. Sastre J, et al. Insights, attitudes, and perceptions about asthma and its treatment: a multinational survey of patients from Europe and Canada. World Allergy Organ J. 2016; 9: 13.
12. Fernandes AG, et al. Risk factors for death in patients with severe asthma. J Bras Pneumol. 2014; 40 (4): 364-372.
13. Wark PA, et al. Asthma exacerbations· 3: pathogenesis. Thorax. 2006; 61 (10): 909-15.
14. Johnson DB, et al. Albuterol. 2022 May 1. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan–. PMID: 29489143.
15. Montemayor T, et al. Albuterol: Often Used and Heavily Abused. Respiratory CareNovember 2021, 66 (Suppl 10) 3603775.
16. ClinCalc.com. Albuterol: Drug Usage Statistics, US 2013 – 2020. Available at: https://clincalc.com/DrugStats/Drugs/Albuterol. [Last accessed: November 2022].
17. Nwaru BI, et al. Overuse of short-acting β2-agonists in asthma is associated with increased risk of exacerbation and mortality: a nationwide cohort study of the global SABINA programme. Eur Respir J. 2020; 55 (4): 1901872.
18. Lloyd A, et al. The impact of asthma exacerbations on health-related quality of life in moderate to severe asthma patients in the UK. Prim Care Respir J. 2007; 16 (1): 22-7.
19. Bourdin A, et al. ERS/EAACI statement on severe exacerbations in asthma in adults: facts, priorities and key research questions. Eur Respir J. 2019; 54 (3): 1900900.
20. Price DB, et al. Adverse outcomes from initiation of systemic corticosteroids for asthma: long-term observational study. J Asthma Allergy. 2018; 11: 193–204.
21. Chipps BE, et al. Evaluation of the Efficacy and Safety of As-Needed PT027 Budesonide/Albuterol MDI) Compared to As-Needed Albuterol MDI in Adults and Children 4 Years of Age or Older with Uncontrolled Moderate to Severe Asthma: Design of the MANDALA Study. Am J Respir Crit Care Med. 2020; 201: A3015.
22. Papi A, et al. Efficacy and safety of as-needed albuterol/budesonide versus as-needed albuterol in adults, adolescents and children aged ≥4 years with moderate-to-severe asthma: Results of the MANDALA study. American Thoracic Society International Conference 2022. Oral Presentation. Abstract A3413 during B93. BREAKTHROUGHS IN PEDIATRIC AND ADULT ASTHMA CLINICAL TRIALS.
23. Clinicaltrials.gov. A Study to Assess the Efficacy and Safety of Budesonide/Albuterol Metered-dose Inhaler (BDA MDI/PT027) Used 4 Times Daily in Adults and Children 4 Years of Age or Older With Asthma (DENALI). Available at https://clinicaltrials.gov/ct2/show/NCT03847896. [Last accessed: November 2022].
24. AstraZeneca Pharmaceuticals. Data on File. DENALI clinical trial protocol Data on File (ID: 121792).
25. LaForce C, et al. Albuterol/budesonide for the treatment of exercise-induced bronchoconstriction in patients with asthma: The TYREE study. Ann Allergy Asthma Immunol.2022; 128: 169-177.

Exercise offers many benefits, even for people with asthma! Exercise can trigger asthma symptoms for some people. This is called exercise-induced bronchoconstriction [BRAHN-koh-kahn-STRIK-shun] – also known as EIB. EIB used to be called exercise-induced asthma.

EIB affects most people who have asthma. The good news is there are ways to manage your asthma so you can exercise. In fact, many professional athletes and Olympians have EIB.

The Asthma and Allergy Foundation of America (AAFA) has a resource to help you manage your asthma and exercise. Visit our webpage on exercise and asthma to learn more about:

• Symptoms of EIB
• How EIB is diagnosed
• How to treat EIB
• What types of sports are best for people with EIB
  
  

Asthma and allergies are chronic diseases that often need daily management and care. When a child with asthma or allergies goes to school, parents and schools need to work together to ensure the child receives appropriate care. What is the best way to work with your child’s school to help prevent asthma episodes or allergic reactions?

Every student with asthma or food allergies should have a school health care plan. A school health care plan lists your child’s common symptoms, medicines, and what to do if they have symptoms. It may also outline what school staff should do to prevent asthma episodes/attacks or allergic reactions.

Three of the most common types of school health care plans are:

• Emergency care plan (ECP)
  • Asthma Action Plan
  • Anaphylaxis Action Plan
• Individual health care plan (IHP or IHCP)
• Section 504 accommodation plan (also known as “504 plan”)
  
  

An IHCP outlines what the school will do to create and maintain a safe school environment for your child. For example, an IHCP will detail what school staff will do to reduce the risk of trigger or allergen exposure, recognize asthma symptoms or an allergic reaction, and give the appropriate treatment.

A Section 504 plan is a contract between you and your child’s school. It addresses how the school will accommodate your child’s asthma or allergies.

If the school already has a solid plan in place for managing asthma and allergies, your child may not need a 504 plan. However, if your child is eligible for a 504 plan, you could request a 504 plan to make the terms of the management plan legally enforceable. (In some cases, your child may not qualify for a 504 plan.)

You as the parent/guardian can work in partnership with school personnel and your child’s doctor as appropriate to develop the contents of your child's IHCP or 504 plan based upon their unique health and safety needs while at school.

The Asthma and Allergy Foundation of America’s (AAFA) School Zone answers questions you may have about 504 plans, such as:

• What is a 504 plan?
• Does my child need an individualized health care plan or a 504 plan?
• How is the IHCP or 504 plan set up?
• What happens if the school doesn’t follow my child’s 504 plan?
• Does a child need a 504 plan in college?
  
  

If you are considering a 504 plan for the next school year, now is a good time to start the process. It can take some time to set up a 504 plan. Follow the steps on our 504 plan article to get started.