New data show that Duaklir achieved the primary endpoints according to the AMPLIFY data, which will be valuable to support a New Drug Application submission to the US Food and Drug Administration.
Spain’s largest drugmaker Almirall (ALM: MC) has announced positive top-line Phase III results, which shows that Duaklir (aclidinium bromide/formoterol 400µg/12µg twice-daily) met the primary endpoints in the AMPLIFY high-level read-out, demonstrating a statistically-significant and clinically-relevant improvement in lung function in moderate to very severe stable chronic obstructive pulmonary disease (COPD) patients compared to each individual component (either aclidinium bromide or formoterol).
The drug is licensed to Anglo-Swedish pharma major AstraZeneca’s (LSE: AZN) in Europe, where it gained approval for the treatment of COPD in November 2014.
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