LAMA/LABA Combo Duaklir Moves Closer To US Filing

07 Sep 2017

• By John Davis

AstraZeneca has released positive top-line data from a new Phase III study of the LAMA/LABA combination, Duaklir, in COPD that could lead to a US NDA filing in 2018, and the start of US marketing by partner Circassia.

Blue sky — Clean air is important for COPD patients. • Source: Shutterstock

Circassia Pharmaceuticals PLC’s plans to build up its respiratory franchise in the US appear to be on track, with its partner AstraZeneca PLC reporting positive top-line data from the Phase III AMPLIFY study of Duaklir (aclidinium bromide and formoterol fumarate 400 µg/12 µg twice daily) inhaler in patients with moderate to severe stable chronic obstructive pulmonary disease (COPD).

The UK biotech says it is looking forward to AstraZeneca filing a US NDA for Duaklir in the coming months – the submission is planned by AstraZeneca for the first...

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