The U.S. FDA has approval AstraZeneca’s Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) for long-term maintenance treatment of airflow obstruction in patients suffering from chronic obstructive pulmonary disease (COPD), including emphysema and/or chronic bronchitis.

Bevespi Aerosphere is an inhaled aerosol used twice daily, with a fixed-dose dual bronchodilator that combines the long-acting muscarinic antagonist (LAMA) glycopyrrolate and the long-acting beta-2 agonist (LABA) formoterol fumarate.

The FDA approved Bevespi Aerosphere based on data from the Phase 3 pivotal clinical program PINNACLE I, PINNACLE II, and a safety extension study, PINNACLE III. The trials enrolled more than 3,700 patients with moderate-to-severe COPD.

Overall, Bevespi Aerosphere:

• Showed statistical significance in the improvement of lung function, as measured by change from baseline in morning pre-dose through forced expiratory volume in one second (FEV1) at 24 weeks compared to its individual components (glycopyrrolate 9 mcg and formoterol fumarate 4.8 mcg) and placebo, twice a day;
• Significantly improved secondary endpoints of peak FEV1 within two hours after dosage, and rescue medication usage, in comparison to placebo; and
• Showed no unexpected adverse events. The most common reactions were urinary tract infection (2.6 percent vs 2.3 percent in the placebo group) and cough (4.0 percent vs 2.7 percent in the placebo).

The drug candidate is the first FDA-approved product that uses AstraZeneca’s Co-Suspension Technology – a system that uses porous, low-density phospholipid particles to provide a stable, homogeneous suspension designed to prevent sedimentation of drug crystals over time, and to prevent them from interacting, allowing for consistent dosing of one or more drugs from a single pressurized metered-dose inhaler.

“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, which enables patients to breathe better and may help them be more active,” said Sean Bohen, AstraZeneca’s executive vice president of Global Medicines Development and chief medical officer, in a press release.

AstraZeneca is a company dedicated to the discovery, development, and commercialization of prescription medicines in three main therapeutic areas – including respiratory, inflammation, and autoimmune disease (RIA).