European Commission OKs Bevespi Aerosphere for Adults With COPD

Bevespi Aerosphere (glycopyrronium/formoterol fumarate), a therapy developed by AstraZeneca, has been approved by the European Commission as a maintenance treatment for adults with chronic obstructive pulmonary disease (COPD).

Bevespi Aerosphere is a combination of two bronchodilators (glycopyrronium and formoterol fumarate) delivered twice daily in a fixed dose using AstraZeneca’s Aerosphere technology. It uses a pressurized metered-dose inhaler (pMDI) to administer the dual treatment efficiently to the patient’s airways.

pMDI devices are particularly helpful to COPD patients with limited lung function, advanced age, and/or reduced dexterity or cognition.

Glycopyrronium is a long-acting muscarinic antagonist (LAMA), which binds to specific receptor proteins in the lung muscles and helps expand the airways (bronchi) to ease air passage. Formoterol fumarate is a long-acting beta2-agonist (LABA) that activates the enzyme adenyl cyclase which helps relax lung muscles.

Positive results from Phase 3 studies of the PINNACLE clinical program were determinant for the European Commission’s decision. The program included the clinical trials PINNACLE I (NCT01854645) and PINNACLE II (NCT01854658) testing the safety and effectiveness of Bevespi Aerosphere in COPD, and a 28-week extension study, PINNACLE III (NCT01970878), evaluating its long-term safety and tolerability.

More than 5,000 participants with moderate-to-severe COPD were involved in the PINNACLE program, and their lung function was assessed pre- and post-treatment. Marked improvements in lung function were reported in patients using Bevespi Aerosphere, compared to those using glycopyrronium or formoterol fumarate alone or a placebo.

“Bevespi Aerosphere is an important treatment option in COPD, particularly for patients with limited lung function and advanced age who may benefit from using a pMDI. The efficacy and safety profile of Bevespi Aerosphere has been well established in the Phase III PINNACLE program,” Omar Usmani, PhD, consultant physician at the National Heart & Lung Institute, Imperial College London and Royal Brompton Hospital, U.K., said in a press release.

In 2016, the U.S. Food And Drug Administration approved Bevespi Aerosphere as a COPD treatment.

“Bevespi Aerosphere is already available to COPD patients in the U.S. and other countries, and this approval means we can now bring this new medicine to patients in Europe,” Colin Reisner, MD, head of respiratory, global medicines development at AstraZeneca said.

In addition to Europe and the U.S., Bevespi Aerosphere also is approved in Australia, Taiwan, Turkey, and Canada.