AstraZeneca's Bevespi Aerosphere fails to outperform GlaxoSmithKline's Anoro Ellipta in COPD trial

AstraZeneca on Thursday announced top-line results from a Phase IIIb study of patients with moderate to very severe chronic obstructive pulmonary disease (COPD), showing that Bevespi Aerosphere (glycopyrronium/formoterol fumarate) was non-inferior to GlaxoSmithKline's Anoro Ellipta (umeclidinium/vilanterol) on peak forced expiratory volume in one second (FEV1), but that it failed to demonstrate superiority on peak FEV1 or non-inferiority on trough FEV1. 

Colin Reisner, head of respiratory, global medicines development at AstraZeneca, said the study results are "inconsistent with previous data," adding that "a full analysis is under way to understand and characterise these findings and will be presented at a forthcoming medical meeting." 

FirstWord reports in this therapy area - KOL Insight COPD: Find out how KOLs expect the market to evolve, which pipeline treatments are most promising, and which clinical trials will shape treatment decisions. Learn more.

The 24-week AERISTO trial randomised 1119 patients with moderate to very severe COPD to receive either two inhalations twice a day of Bevespi Aerosphere via a pressurised metered-dose inhaler or one inhalation once a day of Anoro Ellipta via a dry powder inhaler. The study's main goals were peak change from baseline in FEV1, where non-inferiority and superiority were measured, and change from baseline in trough FEV1, where non-inferiority was measured. AstraZeneca noted that safety and tolerability data for Bevespi Aerosphere were consistent with the therapy's known profile.

Bevespi Aerosphere is currently approved in the US and Canada for the long-term maintenance treatment of airflow obstruction in COPD, while the fixed-dose dual bronchodilator is currently under review in Europe, with a decision expected in the second half of 2018. AstraZeneca has also said it would target regulatory filings for Bevespi Aerosphere in Japan and China this year.

 --------------------------------------------------------------------------------------------------------------------------

Editor's Note:

To apply for becoming a contributor of en-CPhI.cn,

welcome to send your CV and sample works to us,

Email: Julia.Zhang@ubmsinoexpo.com.