Circassia has announced the US Food and Drug Administration (FDA) approval of its chronic obstructive pulmonary disease (COPD) maintenance treatment, Duaklir.
The drug 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), and is administered twice-daily via the breath-actuated inhaler Pressair.
Steve Harris, Circassia’s chief executive, said of the news: “We are delighted with the FDA approval of Duaklir, which we believe will provide a valuable treatment option for the significant number of patients with COPD in the United States.
"The addition of Duaklir to our portfolio further strengthens our range of marketed respiratory products and we look forward to launching it 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.”
The approval is based on data from three Phase III studies, ACLIFORM, AUGMENT and AMPLIFY, and the phase IV ASCENT study, which showed that aclidinium therapy is effective at reducing COPD exacerbations.