FDA Approves New COPD Maintenance Treatment

The FDA has approved AstraZeneca’s glycopyrrolate and formoterol fumarate (Bevespi Aerosphere) inhalation aerosol for long-term maintenance treatment for patients with chronic obstructive pulmonary disease (COPD).

Bevespi Aerosphere is a twice-daily, fixed-dose dual bronchodilator that combines a long-acting muscarcinic antagonist (LAMA) and a long-acting beta-2 agonist (LABA).

“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,” said Sean Bohen, executive vice president of the global medicines department and chief medical officer of AstraZeneca, in a press release. “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.”

The FDA based its approval of Bevespi Aerosphere after reviewing the data from the PINNACLE trial, which showed that the product achieved statistically significant improvement in morning pre-dose forced expiratory volume in 1 second at 24 weeks compared with placebo..

The most common adverse reactions observed in patients during trials were urinary tract infection and cough. There were no unexpected safety issues discovered in the study.