AstraZeneca today announced positive top-line results of the Phase III, PINNACLE 4 trial in which Bevespi Aerosphere* (glycopyrronium and formoterol fumarate 14.4/9.6 µg) demonstrated a statistically significant improvement in lung function as measured by trough forced expiratory volume in one second (FEV1), compared to its monotherapy components (glycopyrronium 14.4 µg and formoterol fumarate 9.6 µg) and placebo, all administered twice daily via pressurised metered-dose inhaler (pMDI) to patients with moderate to very severe chronic obstructive pulmonary disease (COPD). AstraZeneca will make regulatory filing applications for Bevespi Aerosphere in Japan and China in 2018, based on data from PINNACLE 4, as well as previously reported trials.
Dr. Colin Reisner, Head of Respiratory, Global Medicines Development at AstraZeneca, said: “These positive results add to the strong established efficacy and safety profile of Bevespi Aerosphere in the treatment of patients with COPD. PINNACLE 4 will support our regulatory filings in Japan and China where respiratory diseases such as COPD remain a significant and growing public health burden with unmet treatment needs.”
The 24-week PINNACLE 4 trial was designed to provide data on the efficacy and safety of Bevespi Aerosphere. It included 1,756 patients across Asia, Europe and the US. Safety and tolerability data for Bevespi Aerosphere were consistent with previous trials. Data from PINNACLE 4 will be presented at a forthcoming medical meeting.
Bevespi Aerosphere is approved in the US for the long-term maintenance treatment of airflow obstruction in COPD. A Marketing Authorisation Application for Bevespi Aerosphere has been accepted for review by the European Medicines Agency with a regulatory decision anticipated in the second half of 2018.