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ARTICLE | Clinical News

AZ says Phase IIIb data of Bevespi Aerosphere in COPD are 'inconsistent with previous data'

September 21, 2018 4:42 PM UTC

AstraZeneca plc (LSE:AZN; NYSE:AZN) said Bevespi Aerosphere glycopyrrolate/formoterol fumarate met one of three primary endpoints in the Phase IIIb AERISTO trial to treat moderate to very severe chronic obstructive pulmonary disease (COPD). Bevespi Aerosphere was non-inferior to Anoro Ellipta umeclidinium bromide/vilanterol from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) in improving peak forced expiratory volume in 1 second (FEV1) from baseline to week 24.

Bevespi Aerosphere missed the primary endpoints of superiority to Anoro Ellipta in improving peak FEV1 and of non-inferiority to Anoro Ellipta in improving trough FEV1. AZ said the performance of Bevespi Aerosphere in AERISTO is "inconsistent with previous data," and the company plans to conduct a full analysis of the results and present them at a medical meeting...