Bevespi Aerosphere Progressing Toward Regulatory Approval for COPD in Europe, Asia

AstraZeneca’s Bevespi Aerosphere was shown to improve lung function in patients with moderate- to very severe-chronic obstructive pulmonary disease (COPD), in the latest PINNACLE 4 clinical trial. The promising results pave the way for regulatory approval in Europe and Asia.

Bevespi Aerosphere combines two bronchodilators, glycopyrronium (long-acting muscarinic antagonist, LAMA) and formoterol fumarate (long-acting beta-2 adrenergic agonist, LABA), in a pressurized metered-dose inhaler (pMDI) to be administered twice daily. Formerly, the drugs have each been used alone to treat the condition.

The effectiveness and safety of Bevespi Aerosphere has been evaluated through the PINNACLE clinical trial, which included more than 5,000 patients.

The PINNACLE 4 trial (NCT02343458) is a randomized, double-blind, 24-week, placebo-controlled, multi-center study that compared Bevespi Aerosphere (glycopyrronium and formoterol fumarate, 14.4/9.6 µg) administered twice daily via pMDI to glycopyrronium (14.4 µg twice-daily pMDI alone), or formoterol fumarate (9.6 µg twice-daily pMDI alone), and to placebo, in COPD patients.

This trial included 1,756 patients with moderate to very severe COPD in Asia, Europe and the U.S. Lung function was found to improve significantly, as measured through forced expiratory volume in one second (FEV1) — a measure of lung function that assesses the maximal amount of air that can be forcefully exhaled in one second.

Results of the PINNACLE 4 trial will be presented at an upcoming medical conference, but the safety and tolerability of Bevespi Aerosphere was found to be consistent with previous trials.

Bevespi Aerosphere is approved in the U.S. for the long-term maintenance treatment of airflow obstruction in COPD. A Marketing Authorization Application for the therapy is being reviewed by the European Medicines Agency, with a regulatory decision expected in the second half of 2018.

In 2018, AstraZeneca plans to submit regulatory filing applications for Bevespi Aerosphere in Japan and China, based on results from PINNACLE 4, as well as from previously reported trials.

“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.” Colin Reisner, head of Respiratory, Global Medicines Development at AstraZeneca, said in a press release.