The FDA has approved AstraZeneca’s Bevespi Aerosphere glycopyrrolate/formoterol fumarate MDI (formerly PT003) for the treatment of COPD, the company has announced. The product is AstraZeneca’s first to use the Co-Suspension technology patented by Pearl Therapeutics in 2012. AstraZeneca acquired Pearl in 2013.
Data from the Phase 3 PINNACLE trial, which was initiated by Pearl Therapeutics in May 2013, showed statistically significant improvement in lung function for patients using PT003 compared to the individual components and to placebo.
AstraZeneca Executive VP, Global Medicines Development, and Chief Medical Officer Sean Bohen commented, “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.”
Read the AstraZeneca press release.
