AstraZeneca has announced that the Phase 3b AERISTO trial of Bevespi Aerosphere glycopyrronium/formoterol fumarate MDI for moderate to very severe COPD failed to meet 2 out of 3 of its primary endpoints, including non-inferiority to umeclidinium/vilanterol on trough FEV1 and superiority on peak FEV1. Bevespi Aerosphere did demonstrate non-inferiority on peak FEV1.
The FDA approved Bevespi Aerosphere in 2016. The inhaler is also approved in Canada, and an MAA is currently under review in Europe, the company said.
The AERISTO study enrolled 1,119 COPD patients who were treated with either Bevespi Aerosphere twice a day or umeclidinium/vilanterol (Anoro Ellipta) DPI once a day over the 24-week trial.
AstraZeneca Head of Respiratory, Global Medicines Development, Colin Reisner said, “The efficacy and safety of Bevespi Aerosphere has been established by the Phase 3 PINNACLE trial program involving more than 5,000 patients. The performance of Bevespi Aerosphere in AERISTO is inconsistent with previous data. A full analysis is underway to understand and characterize these findings and will be presented at a forthcoming medical meeting.”
Read the AstraZeneca press release.
