AstraZeneca shocked as inhaler fails to outclass GSK rival in COPD

Researchers at AstraZeneca have been left scratching their heads as new Phase 3b results for its inhaler, Bevespi Aerosphere, posted disappointing results compared to a rival product, GSK’s Anoro (umeclidinium/vilanterol), in the treatment of moderate to very severe chronic obstructive pulmonary disease (COPD) – results which the company says are inconsistent with previous findings.

Bevespi Aerosphere is a fixed-dose dual bronchodilator which combines the long-acting muscarinic agonist (LAMA) glycopyrronium with the long-acting beta2-agonist (LABA) formoterol fumarate, making it unique among inhalers. It is currently approved in both the US and Canada as a long-term maintenance treatment for airflow obstruction in COPD, and is currently awaiting review in Europe with a decision expected later this year.

The therapy was found to be non-inferior to Anoro in on peak forced expiratory volume in one second (FEV1), but failed to prove more effective on peak FEV1 or non-inferiority on trough FEV1in a 24-week trial of 1,119 participants.

"The efficacy and safety of Bevespi Aerosphere has been established by the Phase3 PINNACLE trial programme involving more than 5,000 patients. The performance of Bevespi Aerosphere in AERISTO is inconsistent with previous data," remarked Dr Colin Reisner, Head of Respiratory, Global Medicines Development at AstraZeneca. "A full analysis is underway to understand and characterise these findings and will be presented at a forthcoming medical meeting."

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