ARTICLE | Clinical News

Duaklir Genuair meets in Phase III to treat COPD

December 1, 2017 10:05 PM UTC

In September, AstraZeneca plc (LSE:AZN; NYSE:AZN) reported data from the Phase III AMPLIFY trial in about 1,595 patients with chronic obstructive pulmonary disease (COPD) showing that Duaklir Genuair aclidinium bromide/formoterol (Brimica, KRP-AB1102F, LAS40464) met the co-primary endpoint of improving forced expiratory volume in 1 second (FEV1) from baseline vs. aclidinium bromide or formoterol alone. Duaklir Genuair also met the co-primary endpoint of non-inferiority to tiotropium bromide in improving FEV1. The company plans to submit an NDA for Duaklir Genuair to treat COPD in 1H18.

Patients received 400µg/12µg aclidinium bromide/formoterol twice daily for 24 weeks. The double-blind, international trial’s secondary endpoints include the St. George’s respiratory Questionnaire (SGRQ) total score...