FDA Approves Bevespi Aerosphere for COPD Patients
The U.S. Food and Drug Administration (FDA) has approved Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) inhalation aerosol for the maintenance treatment of COPD. This approval marks the availability of a new dual bronchodilator option delivered via a pressurized metered-dose inhaler.
AstraZeneca announced that the U.S. Food and Drug Administration (FDA) has approved Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) inhalation aerosol. The medication is 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 a twice-daily, fixed-dose dual bronchodilator. It combines glycopyrrolate, a long-acting muscarinic antagonist (LAMA), with formoterol fumarate, a long-acting beta-2 agonist (LABA). This approval represents the first LAMA/LABA delivered through a pressurized metered-dose inhaler (pMDI) and utilizes AstraZeneca's patented Co-Suspension™ Technology.
The FDA's decision was based on the PINNACLE trial program. These studies demonstrated that Bevespi Aerosphere achieved a statistically significant improvement in lung function, specifically in morning pre-dose forced expiratory volume in 1 second (FEV1) at 24 weeks, when compared to its individual components and placebo. This improvement is expected to help patients breathe better.
This product is the first to be approved using AstraZeneca's Co-Suspension Technology, designed to enable consistent delivery of one or more medicines from a single pMDI. The company is applying this technology to other inhaled combination therapies for respiratory conditions currently in development.