April 25, 2016 19:36 ET
Demonstrated Superior Improvement in Lung Function Versus Mono-Components and Placebo Only Long Acting Dual Bronchodilator Delivered Through a Pressurized Metered-Dose Inhaler (pMDI) and First Product to Use AstraZeneca's Patented Co-Suspension™ Technology
Demonstrated Superior Improvement in Lung Function Versus Mono-Components and Placebo
Only Long Acting Dual Bronchodilator Delivered Through a Pressurized Metered-Dose Inhaler (pMDI) and First Product to Use AstraZeneca's Patented Co-Suspension™ Technology
WILMINGTON, DE--(Marketwired - 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 9 mcg/4.8 mcg) is a twice-daily, fixed-dose dual bronchodilator combining glycopyrrolate, a long-acting muscarinic antagonist (LAMA), and formoterol fumarate, a long-acting beta-2 agonist (LABA). The FDA approval is based on the PINNACLE trial program, which demonstrated that BEVESPI AEROSPHERE achieved statistically significant improvement in morning pre-dose forced expiratory volume in 1 second (FEV1) at 24 weeks (p < 0.001) versus its mono-components and placebo.
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).
BEVESPI AEROSPHERE is a combination of glycopyrrolate, an anticholinergic, and formoterol fumarate, a long-acting beta2-adrenergic agonist (LABA), 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 for the relief of acute bronchospasm or for the treatment of asthma.
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 paradoxical bronchospasm occurs, discontinue BEVESPI immediately and institute alternative therapy.
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.
NOTES TO EDITORS
COPD (chronic obstructive pulmonary disease) is a progressive disease associated mainly with tobacco smoking, air pollution or occupational exposure, which can cause obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness. It affects an estimated 329 million people worldwide and is predicted to be the third leading cause of death by 2030. Improving lung function and managing daily symptoms such as breathlessness are important to the management of COPD.
About Co-Suspension Technology
The Co-Suspension Technology uses porous, low-density phospholipid particles, which are designed to form a uniform suspension inside a pressurized metered-dose inhaler (pMDI) and distribution of drug crystals throughout the lungs for release at their sites of deposition.
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
The FDA approval of BEVESPI AEROSPHERE is based on data from the PINNACLE 1, PINNACLE 2, and a safety extension study, PINNACLE 3. Overall the Phase III pivotal program enrolled over 3,700 patients with moderate to very severe COPD.
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
Respiratory, Inflammation and Autoimmunity (RIA), one of AstraZeneca's main therapy areas, has five potential medicines in pivotal trials or under registration. In respiratory disease, our aim is to transform asthma and COPD treatment through: Inhaled combinations at the core of care, precision 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 unique porous particle Co-Suspension Technology.
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.
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three main therapy areas -- respiratory, inflammation, autoimmune disease (RIA), cardiovascular and metabolic disease (CVMD) and oncology -- as well as in infection and neuroscience. 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
Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD - Cardiovascular and Metabolic Disease,
ING - Infection, Neuroscience and Gastrointestinal
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