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Tagged With "biologic therapy"

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AAFA Urges Inclusion of Patient Voice in Analysis of Costly New Asthma Drugs

AAFA Community Services ·
Biologics are a new class of drugs that fight disease at the source . Instead of attacking symptoms, these drugs target diseases like asthma at a molecular level. These newer types of drugs are more expensive than older medicines. That is prompting public discussion on how to pay for them. The cost of caring for patients with the most severe forms of asthma represents a majority of asthma healthcare spending. In addition, asthma is a leading cause of missed time from work and school. Last...
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Dupixent® Shows Positive Results in Phase 3 of Trial for Ages 6 to 11 With Severe Atopic Dermatitis

AAFA Community Services ·
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that a pivotal Phase 3 trial evaluating Dupixent® (dupilumab) to treat severe atopic dermatitis in children aged 6 to 11 years met its primary and secondary endpoints. Dupixent is the first and only biologic to show positive results in this pediatric atopic dermatitis population.
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FDA Approves FASENRA® Pre-Filled Auto-Injector Pen for Self-Administration

AAFA Community Services ·
AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved the self-administration of FASENRA® (benralizumab) in a pre-filled, single-use auto-injector (the FASENRA Pen™).
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FDA Considers Biologic Dupilumab for Children Ages 6 to 11 Years With Moderate-to-Severe Atopic Dermatitis

AAFA Community Services ·
Regeneron Pharmaceuticals, Inc. and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) as an add-on maintenance treatment for children aged 6 to 11 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
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FDA Will Consider Xolair for the Treatment of Nasal Polyps

AAFA Community Services ·
Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Xolair® (omalizumab) for the treatment of nasal polyps in adult patients 18 years of age and older with inadequate response to intranasal corticosteroids.
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What Is a Biologic?

AAFA Community Services ·
Biologics are targeted therapies made from living organisms or natural sources. Biologic therapy involves injections every few weeks or so that are tailored to the individual. Biologics help normalize your immune system by controlling immune responses that lead to inflammation. There are biologic treatments available for people with moderate-to-severe asthma or atopic dermatitis (eczema).
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Xolair Approved for Children with Asthma Triggered by Allergens

AAFA Community Services ·
There is a new drug available for children with uncontrolled asthma caused by airborne allergens. Xolair is already approved for people, ages 12 and older, with moderate to severe asthma. It belongs to a class of drugs called biologics. It is given in a doctor’s office by injection. The FDA recently approved it for children between ages 6 and 11 whose asthma is not controlled with other long-term medications . Approval makes Xolair the only biologic for children with uncontrolled allergic...
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New Eczema Drug Dupixent Approved by FDA

AAFA Community Services ·
The U.S. Food and Drug Administration today approved Dupixent (dupilumab) injection to treat adults with moderate-to-severe eczema (atopic dermatitis). Dupixent is intended for patients whose eczema is not controlled adequately by topical therapies, or those for whom topical therapies are not advisable. Dupixent can be used with or without topical corticosteroids.
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Re: New Eczema Drug Dupixent Approved by FDA

OneWoman ·
I was just wondering if anyone has any knowledge or experience with Dupixent and Dyshidrotic Eczema? I have had it for almost 2 years now. I have tried everything I know to do, as well as Rx creams from my Dr., and nothing helps...not even a little. The skin on my hands (back, front, sides, all fingers- sides, top, bottom) is so thick and itches so bad all the time. The only way I can relieve the itching is by popping the blisters. I'm about to go insane. I don't know what to do. The subject...
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Re: New Eczema Drug Dupixent Approved by FDA

Kathy P ·
Welcome One Woman. I don't know that it has been approved for dyshidrotic eczema, but it's worth talking to the doctor. Have you figured out any triggers that make it worse?
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Re: New Eczema Drug Dupixent Approved by FDA

Jen ·
@OneWoman What did your doctor have to say about Dupixent?
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Re: New Eczema Drug Dupixent Approved by FDA

OneWoman ·
@Jen would you know I had an appt with her last week, and I completely spaced this med out. I did talk to her about my eczema, and she did prescribe me a steroid cream (again), but, I forgot to ask about Dupixent. Rats! Not sure when I'll be going in to see her again, either...
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Re: New Eczema Drug Dupixent Approved by FDA

Jen ·
Do you feel like the steroid cream is helping?
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Re: Xolair Approved for Children with Asthma Triggered by Allergens

Sgp8136 ·
Thank you for sharing your experience. My 10 year old is going to be starting Xolair very soon, we finally got the approval from our insurance. I’m hoping this is just what she needs. She has been hospitalized so many times and is constantly absent from school because of her asthma not to mention all the steroids she’s taken. We’ve tried so many different preventative medications and it just isn’t enough. I hope all goes well and there aren’t any side effects the possibility of that is...
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Re: Xolair Approved for Children with Asthma Triggered by Allergens

K8sMom2002 ·
Welcome, SGP8136! I am hoping that your daughter will do well on the Xolair and will see improvements! Please know that you guys aren't alone as you go along ... you'll find plenty of support on AAFA's Asthma Support Community .
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Re: Xolair Approved for Children with Asthma Triggered by Allergens

JadesJourney ·
Jade just started her first round of Xolair Injections this past week. She's SO brave! But...I have to admit...It was a bittersweet moment; watching her sit there, calm, asking the nurse to count slowly for her, watching the needle, as she was given both injections. Outside of respectfully saying that it "kind of hurt, a lot", she didn't complain, or cry, or move, or refuse, or scream...she just sat still and watched! As a mom, this was a like a dream come true...at first. [{Sidebar} At this...
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Re: Xolair Approved for Children with Asthma Triggered by Allergens

Jen ·
@JadesJourney That is great that Jade is so brave during those shots. We have other members who have been on xolair as well and have discussed their experiences on our support forums.
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Re: Xolair Approved for Children with Asthma Triggered by Allergens

K8sMom2002 ·
I totally get what you're saying here, @JadesJourney ... fingers crossed that these shots will give her some control over her asthma that has been lacking! WTG on you helping guide her so that she CAN ask those "big girl" questions about the medications she's on. Hang tight, Mama!
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Re: Xolair Approved for Children with Asthma Triggered by Allergens

Jen ·
@JadesJourney How are things going with the Xolair?
Blog Post

FDA Approves Dupixent® (Dupilumab) for Children Aged 6 to 11 Years With Moderate-to-Severe Atopic Dermatitis

AAFA Community Services ·
The U.S. Food and Drug Administration (FDA) approved Dupixent® (dupilumab) for children aged 6 to 11 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupixent is the only biologic medicine approved for this patient population.
Blog Post

FDA Accepts Biologics License Application for Xolair® Prefilled Syringe for Self-Administration

AAFA Community Services ·
Novartis today announced that the US Food and Drug Administration (FDA) accepted the company's supplemental Biologics License Application (sBLA) for a new self-administration option for Xolair® (omalizumab) across all approved US indications. If approved, Xolair prefilled syringe would become available for either self-administration by select patients or administration by their caregivers.
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FDA Approves Xolair® (Omalizumab) Prefilled Syringe for Self-Injection

AAFA Community Services ·
Novartis today announced that the US Food and Drug Administration (FDA) approved the supplemental Biologics License Application for Xolair® (omalizumab) prefilled syringe for self-injection in appropriate patients across all approved US indications.1 Xolair is the only FDA-approved biologic designed to target and block immunoglobulin E (IgE) for the treatment of moderate to severe persistent allergic asthma, chronic idiopathic urticaria (CIU) and nasal polyps.
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Re: FDA Approves Xolair® (Omalizumab) Prefilled Syringe for Self-Injection

Kathy P ·
If you are currently on Xolair or considering it, what are your thoughts about self injections? Excited that this will make things more convenient? Apprehensive about doing the shots at home instead of a clinic? Join the discussion !
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Re: FDA Approves Xolair® (Omalizumab) Prefilled Syringe for Self-Injection

katalinfrog ·
I've been on Xolair injections for 8 months now, and we're doubling my dose since my IgE levels are still very high. Even though the FDA has approved injecting at home, my physician's office is still apprehensive about allowing me to inject at home. I have Epi pens and I'm ready to make the switch. It will save me an hour round trip, and $65 per injection. Is it typical for doctor's offices to be nervous about switching?
Blog Post

Amgen Submits Biologics License Application for Tezepelumab for Severe Asthma

AAFA Community Services ·
Amgen today announced its partner AstraZeneca submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for tezepelumab, a potential first-in-class medicine in severe asthma.
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