The US FDA has approved twice-daily Duaklir, a fixed-dose combination LAMA/LABA for the maintenance treatment of COPD, according to manufacturer Circassia Pharmaceuticals.
Duaklir is a fixed-dose combination of the LAMA aclidinium bromide (400 mcg) and LABA formoterol fumarate (12 mcg) and is administered twice-daily via AstraZeneca’s Pressair breath-actuated inhaler.
The approval is based on data from three phase III studies: ACLIFORM, AUGMENT and AMPLIFY. The label also includes clinical data from the phase IV ASCENT study, which shows aclidinium therapy is effective at reducing COPD exacerbations.
According to Circassia Pharma, Duaklir is the only twice-daily LAMA/LABA in the US with COPD exacerbation data included in its prescribing information.
“We look forward to launching [Duaklir] in the US in the coming months alongside our aclidinium monotherapy, Tudorza, as part of the significant LAMA/LABA market that is predicted to grow rapidly over the coming years,” said Steve Harris, Circassia’s chief executive.
Circassia expects to launch Duaklir in the United States in the second half of 2019, the company said in a news release.
According to Medscape, aclidinium bromide and formoterol fumarate have already been individually approved for COPD in the United States and Europe, while the Duaklir combination was approved by the European Medicines Agency for COPD in 2014.