US FDA approves SYMBICORT for the treatment of asthma in pediatric patients

[Press Release]

AstraZeneca announced that the US Food and Drug Administration (FDA) approved SYMBICORT® (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol 80/4.5 micrograms for the treatment of asthma in pediatric patients aged six up to 12 years. SYMBICORT 80/4.5 and 160/4.5 are already approved in the US to treat asthma in patients 12 years and older. SYMBICORT 160/4.5 is also approved for the maintenance treatment of airflow obstruction in Chronic Obstructive Pulmonary Disease (COPD) in adults.

The FDA approval is based on the CHASE (ChildHood Asthma Safety and Efficacy) clinical trial program, which included the CHASE 3 Phase III trial. This trial demonstrated SYMBICORT 80/4.5 micrograms delivered in a pressurized metered-dose inhaler (pMDI) significantly improved lung function in pediatric patients with asthma aged six up to 12 years who were symptomatic on low-dose inhaled corticosteroid versus budesonide pMDI 80 micrograms, both delivered as two inhalations twice daily. The safety profile in pediatric patients aged six up to 12 years is similar to the safety profile in patients aged 12 years and older. Common adverse reactions that occurred in patients treated with SYMBICORT 80/4.5 with a frequency of ≥3% and more frequently than patients treated only with budesonide pMDI 80 micrograms included upper respiratory tract infection, pharyngitis, headache, and rhinitis.

Gregory Keenan, Vice President, Medical Affairs and US Head Medical Officer, said:

“SYMBICORT is a cornerstone product in our growing respiratory franchise and we are pleased to now be able to offer this medicine to younger patients, helping to control and prevent asthma symptoms.”

With this expanded indication, SYMBICORT can now be used to treat a wider range of patients suffering from asthma. SYMBICORT is an ICS/LABA (inhaled corticosteroid/long-acting beta2-agonist bronchodilator) controller medication that has been shown to help control asthma by reducing inflammation in the lungs and keeping airways open. It is not indicated for the relief of acute bronchospasm.

An estimated 6.3 million children under the age of 18 years in the US have been diagnosed with asthma. Well-controlled asthma results in the prevention of symptoms such as coughing or wheezing and can help maintain good lung function and normal activity.

INDICATIONS

SYMBICORT is indicated for the treatment of asthma in patients 6 years and older (also see Boxed WARNING and DOSAGE AND ADMINISTRATION).

SYMBICORT 160/4.5 is indicated for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

SYMBICORT is NOT indicated for the relief of acute bronchospasm.

IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING

• WARNING: Long-acting beta2-adrenergic agonists (LABA), such as formoterol, one of the active ingredients in SYMBICORT, increase the risk of asthma-related death. A placebo-controlled study with another LABA (salmeterol) showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of LABA, including formoterol. Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABA. Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients
  
  
• When treating patients with asthma, prescribe SYMBICORT only for patients not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (eg, discontinue SYMBICORT) if possible without loss of asthma control, and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use SYMBICORT for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids
  
  
• SYMBICORT is NOT a rescue medication and does NOT replace fast-acting inhalers to treat acute symptoms
  
  
• SYMBICORT should not be initiated in patients during rapidly deteriorating episodes of asthma or COPD
  
  
• Patients who are receiving SYMBICORT should not use additional formoterol or other LABA for any reason
  
  
• Localized infections of the mouth and pharynx with Candida albicans has occurred in patients treated with SYMBICORT. Patients should rinse the mouth after inhalation of SYMBICORT
  
  
• Lower respiratory tract infections, including pneumonia, have been reported following the inhaled administration of corticosteroids
  
  
• Due to possible immunosuppression, potential worsening of infections could occur.
  
  
• A more serious or even fatal course of chickenpox or measles can occur in susceptible patients
  
  
• It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression may occur, particularly at higher doses. Particular care is needed for patients who are transferred from systemically active corticosteroids to inhaled corticosteroids. Deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids
  
  
• Caution should be exercised when considering administration of SYMBICORT in patients on long-term ketoconazole and other known potent CYP3A4 inhibitors
  
  
• As with other inhaled medications, paradoxical bronchospasm may occur with SYMBICORT
  
  
• Immediate hypersensitivity reactions may occur, as demonstrated by cases of urticaria, angioedema, rash, and bronchospasm
  
  
• Excessive beta-adrenergic stimulation has been associated with central nervous system and cardiovascular effects. SYMBICORT should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension
  
  
• Long-term use of orally inhaled corticosteroids may result in a decrease in bone mineral density (BMD). Since patients with COPD often have multiple risk factors for reduced BMD, assessment of BMD is recommended prior to initiating SYMBICORT and periodically thereafter
  
  
• Orally inhaled corticosteroids may result in a reduction in growth velocity when administered to pediatric patients
  
  
• Glaucoma, increased intraocular pressure, and cataracts have been reported following the inhaled administration of corticosteroids, including budesonide, a component of SYMBICORT. Close monitoring is warranted in patients with a change in vision or history of increased intraocular pressure, glaucoma, or cataracts
  
  
• In rare cases, patients on inhaled corticosteroids may present with systemic eosinophilic conditions
  
  
• SYMBICORT should be used with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, and in patients who are unusually responsive to sympathomimetic amines
  
  
• Beta-adrenergic agonist medications may produce hypokalemia and hyperglycemia in some patients
  
  
• The most common adverse reactions ≥3% reported in asthma clinical trials included nasopharyngitis, headache, upper respiratory tract infection, pharyngolaryngeal pain, sinusitis, pharyngitis, rhinitis, influenza, back pain, nasal congestion, stomach discomfort, vomiting, and oral candidiasis
  
  
• The most common adverse reactions ≥3% reported in COPD clinical trials included nasopharyngitis, oral candidiasis, bronchitis, sinusitis, and upper respiratory tract infection
  
  
• SYMBICORT should be administered with caution to patients being treated with MAO inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents
  
  
• Beta-blockers may not only block the pulmonary effect of beta-agonists, such as formoterol, but may produce severe bronchospasm in patients with asthma
  
  
• ECG changes and/or hypokalemia associated with nonpotassium-sparing diuretics may worsen with concomitant beta-agonists. Use caution with the coadministration of SYMBICORT

Please see full Prescribing Information, including Boxed WARNING and Medication Guide.

NOTES TO EDITORS

About Asthma
Asthma is the most common chronic respiratory disease and it affects the health and day-to-day lives of more than 300 million adults and children worldwide. It is characterized by recurrent breathlessness and wheezing, which vary in severity and frequency from person to person.

About SYMBICORT
SYMBICORT is a combination formulation containing budesonide, an inhaled corticosteroid (ICS), and formoterol, a long-acting beta2-agonist bronchodilator (LABA), in a single inhaler.

About AstraZeneca in Respiratory Disease
Respiratory disease is one of AstraZeneca’s main therapy areas, and we have a growing portfolio of medicines that reached more than 17 million patients in 2015. Our aim is to transform asthma and COPD treatment through inhaled combinations at the core of care, biologics for the unmet needs of specific patient populations, and scientific advancements in disease modification. We are building on a 40-year heritage in respiratory disease, and our capability in inhalation technology spans both pressurized metered-dose inhalers (pMDIs) and dry powder inhalers (DPIs), as well as our innovative Co-SuspensionTM Delivery Technology. Our research is focused on four key biological pathways: eosinophilic disease, Th2-driven disease, epithelial-driven pathobiology and autoimmunity.

About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three main therapy areas - Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. 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.

CONTACTS

Media Inquiries

Michele Meixell +1 302 885 2677
Abigail Bozarth +1 302 885 2677