US FDA approves Duaklir inhaler for COPDJune 9, 2019
The US FDA has approved Duaklir Pressair for the maintenance treatment of chronic obstructive pulmonary disease (COPD).
Duaklir Pressair combines aclidinium bromide, a long-acting muscarinic antagonist (LAMA), and formoterol fumarate, a long-acting beta2 -adrenergic agonist (LABA). It is intended for twice-daily use with the breath-actuated Pressair inhaler.
The approval was supported by data from the phase 3 ACLIFORM, AUGMENT, and AMPLIFY studies which included patients with moderate to very severe COPD.
Results showed that treatment with Duaklir Pressair led to a statistically significant increase in mean change from baseline in trough FEV1 and change from baseline in 1-hour post-dose FEV1 at week 24 relative to formoterol fumarate 12mcg and aclidinium 400mcg, respectively.
Circassia who is planning to launch Duaklir in the US in the second half of 2019 via its dedicated COPD sales force.