AstraZeneca’s Bevespi Aerosphere Receives FDA Approval for COPD Treatment

AstraZeneca recently announced that its bronchodilator inhalation aerosol medicine Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) has been approved by the U.S. Food and Drug Administration (FDA) for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), namely, patients suffering from chronic bronchitis and/or emphysema. Bevespi Aerosphere is the first product developed under AstraZeneca’s Co-Suspension Technology to be approved.

Bevespi Aerosphere is a twice-daily, fixed-dose dual bronchodilator that combines glycopyrrolate, a long-acting muscarinic antagonist (LAMA), and formoterol fumarate, a long-acting beta-2 agonist (LABA). It was developed under AstraZeneca’s Co-Suspension Technology, which uses porous, low-density particles designed to form a stable and homogenized suspension inside a pressurised metered-dose inhaler (pMDI), preventing sedimentation of drug crystals over time, and allowing consistent dosing of different drugs.

The FDA approval of the drug stems from the positive results of the Phase III PINNACLE trial programme, which included PINNACLE 1, PINNACLE 2, and a safety extension study, PINNACLE 3. The program enrolled over 3,700 patients with moderate to very severe COPD. Results indicated that the drug led to a statistically significant improvement in lung function, as measured by change from baseline through forced expiratory volume in 1 second (FEV1), as compared to the individual components of the medicine, glycopyrrolate and formoterol fumarate, and placebo.

Moreover, Bevespi Aerosphere also performed well on secondary endpoints, demonstrating significant improvement in peak FEV1 within 2 hours post-dose, when compared to placebo, and as rescue medication usage. As observed during the development stage, no unexpected safety concerns were found during the PINNACLE trials. The most common adverse reactions with Bevespi Aerosphere were urinary tract infection (2.6% vs 2.3% with placebo) and cough (4.0% vs 2.7% with placebo).

“With the approval of Bevespi Aerosphere we are pleased to provide patients with the first LAMA/LABA in a pressurised 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, which enables patients to breathe better and may help them be more active,” said Sean Bohen, Executive Vice-President, Global Medicines Development and Chief Medical Officer, in a news release.