LONDON (dpa-AFX) - AstraZeneca plc (AZN.L, AZN) announced positive top-line results from the Phase III AMPLIFY trial for Duaklir (aclidinium bromide/formoterol 400µg/12µg twice-daily), which met its primary endpoints. According to the company, the study achieved the primary endpoints to support a New Drug Application or NDA submission.
AstraZeneca noted that the trial demonstrated a statistically-significant improvement in lung function in patients with moderate to very severe stable chronic obstructive pulmonary disease or COPD compared to each individual component, either aclidinium bromide or formoterol.
In addition, aclidinium bromide achieved its primary bronchodilation endpoint of demonstrating non-inferiority to tiotropium bromide 18µg once-daily.
Dr. Sanjay Sethi, Professor and Chief, Pulmonary, Critical Care and Sleep Medicine at University at Buffalo, The State University of New York, USA and the lead investigator of the trial, said, 'These results demonstrate the improvement in lung function achieved by the combination of aclidinium and formoterol compared to single LAMA bronchodilators tiotropium and aclidinium, with comparable safety.'
AstraZeneca noted that a full evaluation of the AMPLIFY data is ongoing and further results will be presented at a forthcoming medical meeting.
The company is expected to submit an NDA during the first half of 2018 to the US Food and Drug Administration for Duaklir, based on the AMPLIFY data.
Copyright RTT News/dpa-AFX