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BEVESPI AEROSPHERE™ APPROVED BY THE US FDA FOR PATIENTS WITH COPDDemonstrated superior improvement in lung function versus mono-components and placeboOnly long acting dual bronchodilator delivered through a pressurized metered-dose inhaler (pMDI) and first product to use AstraZeneca’s patented
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April 25, 2016 AstraZeneca today announced that the US Food and Drug Administration has approved BEVESPI AEROSPHERE (glycopyrrolate and formoterol fumarate) inhalation aerosol indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. BEVESPI AEROSPHERE is not indicated to treat asthma or for the relief of acute bronchospasm. Sean Bohen, Executive Vice-President, Global Medicines Development and Chief Medical Officer, said: “With the approval of BEVESPI AEROSPHERE we are pleased to provide patients with the first LAMA/LABA in a pressurized metered-dose inhaler, delivered using our unique formulation technology. LAMA/LABAs are emerging as a preferred treatment option for many COPD patients. This class aims to provide maximum bronchodilation, enabling patients to breathe better and may help them be more active.” BEVESPI AEROSPHERE (glycopyrrolate/formoterol fumarate LABAs, such as formoterol fumarate, one of the active ingredients in BEVESPI AEROSPHERE, increase the risk of asthma-related death. The most common adverse reactions with BEVESPI AEROSPHERE were urinary tract infection and cough. BEVESPI AEROSPHERE is the first product approved using AstraZeneca’s Co-Suspension Technology. This technology enables consistent delivery of one or more different medicines from a single pMDI. The technology is being applied to a range of AstraZeneca respiratory inhaled combination therapies currently in clinical development, such as the fixed-dose triple combination of LAMA/LABA/Inhaled corticosteroid (PT010). INDICATION Important Safety Information about BEVESPI AEROSPHERE, including Boxed WARNING WARNING: Long-acting beta2-adrenergic agonists (LABAs), such as formoterol fumarate, one of the active ingredients in BEVESPI AEROSPHERE, increase the risk of asthma-related death. A placebo-controlled trial with another LABA (salmeterol) showed an increase in asthma-related deaths in subjects receiving salmeterol. This finding with salmeterol is considered a class effect of all LABAs, including formoterol fumarate. The safety and efficacy of BEVESPI AEROSPHERE in patients with asthma have not been established. BEVESPI AEROSPHERE is not indicated for the treatment of asthma. All LABAs are contraindicated in patients with asthma without use of a long-term asthma control medication. BEVESPI is contraindicated in patients with a hypersensitivity to glycopyrrolate, formoterol fumarate, or to any component of the product. BEVESPI should not be initiated in patients with acutely deteriorating COPD, which may be a life-threatening condition. BEVESPI should not be used for the relief of acute symptoms, i.e., as rescue therapy for acute episodes of bronchospasm. Acute symptoms should be treated with an inhaled short-acting beta2-agonist. BEVESPI should not be used more often or at higher doses than recommended, or with other LABAs, as an overdose may result. If immediate hypersensitivity reactions, including angioedema, urticaria, or skin rash, occur, discontinue BEVESPI at once and consider alternative treatment. BEVESPI can produce a clinically significant cardiovascular effect in some patients, as measured by increases in pulse rate, blood pressure, or symptoms. If such effects occur, BEVESPI may need to be discontinued. Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, and in patients who are unusually responsive to sympathomimetic amines. Be alert to hypokalemia and hyperglycemia. Worsening of narrow-angle glaucoma or urinary retention may occur. Use with caution in patients with narrow-angle glaucoma, prostatic hyperplasia, or bladder-neck obstruction and instruct patients to contact a physician immediately if symptoms occur. The most common adverse reactions with BEVESPI (≥2% and more common than placebo) were: cough, 4.0% (2.7%), and urinary tract infection, 2.6% (2.3%). Use caution if administering adrenergic drugs because the sympathetic effects of formoterol may be potentiated. Concomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate any hypokalemic effect of formoterol. Use with caution in patients taking non–potassium-sparing diuretics, as the ECG changes and/or hypokalemia may worsen with concomitant beta2-agonists. The action of adrenergic agonists on the cardiovascular system may be potentiated by monoamine oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the QTc interval. Therefore BEVESPI should be used with extreme caution in patients being treated with these agents. Use beta-blockers with caution as they not only block the therapeutic effects of beta-agonists, but may produce severe bronchospasm in patients with COPD. Avoid co-administration of BEVESPI with other anticholinergic-containing drugs as this may lead to an increase in anticholinergic adverse effects. Please see full Prescribing Information including Boxed WARNING, and Medication Guide.
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NOTES TO EDITORS About COPD About Co-Suspension Technology In addition, Co-Suspension Technology addresses issues often seen when multiple drugs are combined in a pMDI. This technology provides a stable, homogeneous suspension designed to prevent sedimentation of drug crystals over time and to prevent drug crystals from interacting with one another, thus allowing for consistent dosing of one or more different drugs from a single pMDI. About the PINNACLE studies BEVESPI AEROSPHERE demonstrated statistically significant improvements in lung function as measured by change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) at 24 weeks (p<0.001) versus its individual components (glycopyrrolate 9 mcg and formoterol fumarate 4.8 mcg),and placebo, all dosed as 2 inhalations twice daily. BEVESPI AEROSPHERE demonstrated a significant improvement versus placebo on secondary endpoints of peak FEV1 within 2 hours post-dose and rescue medication usage. There were no unexpected safety findings with adverse events consistent with previous results from the development program. The most common adverse reactions with BEVESPI AEROSPHERE, (with a ≥ 2% incidence and more common than with placebo) were urinary tract infection (2.6% vs 2.3% with placebo) and cough (4.0% vs 2.7% with placebo). About Respiratory, Inflammation and Autoimmunity Diseases In Inflammation and Autoimmunity, our aim is to develop innovative therapies for the treatment of autoimmune and rheumatoid diseases, with a lead program in systemic lupus erythematosus. Across respiratory, inflammation and autoimmune diseases, our research is focused on four key treatable traits: eosinophilic disease, Th2-driven disease, epithelial-driven pathobiology, and autoimmunity. About AstraZeneca CONTACTS
Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD - Cardiovascular and Metabolic Disease,
3226101 Last Updated 4/16 |
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