AstraZeneca has announced positive top-line from the Phase 3 AMPLIFY study of the Duaklir aclidinium bromide/formoterol DPI in patients with moderate to very severe COPD. The study met its primary endpoints by demonstrating statistically significant improvement in lung function for patients using Duaklir compared to the individual components and by demonstrating non-inferiority to tiotropium.
The company said that it plans to submit an NDA for Duaklir based on the data from the AMPLIFY study in the first half of 2018. Duaklir Genuair has been approved in Europe since November 2014.
AstraZeneca Global Medicine Leader, Respiratory, Steve Lewington, commented, “The AMPLIFY study top-line results provide further clinical evidence of Duaklir’s efficacy and support making this LAMA/LABA combination treatment option available to COPD patients in the US.”
Read the AstraZeneca press release.