Circassia Pharmaceuticals plc has received FDA approval for Duaklir® for the maintenance treatment of chronic obstructive pulmonary disease (COPD). Duaklir is a fixed-dose combination of the long-acting muscarinic antagonist (LAMA) aclidinium bromide (400 mcg) and long-acting beta-agonist (LABA) formoterol fumarate (12 mcg), administered twice-daily via the Pressair® inhaler.
The approval is partly based on data from three phase 3 studies, ACLIFORM, AUGMENT, and AMPLIFY. Duaklir’s label includes data from the phase 4 ASCENT study, demonstrating the efficacy of aclidinium therapy in reducing COPD exacerbations. This makes Duaklir the only twice-daily LAMA/LABA in the U.S. with COPD exacerbation data included in its prescribing information.
COPD is the third leading cause of death in the U.S., causing more than 120,000 deaths annually. More than 12 million people have been diagnosed with the condition, but an additional 12 million are estimated to have COPD without knowing it.
Circassia expects to launch Duaklir in the U.S. in the second half of 2019.
Source: Circassia, April 1, 2019