FDA Approves Combination Therapy for COPD Maintenance

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) has been approved by the FDA for the maintenance treatment of chronic obstructive pulmonary disease (COPD).

The combination treatment (Duaklir, Circassia) is designed to be administered twice-daily via AstraZeneca’s breath-actuated inhaler (Pressair).

“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,” said Steve Harris, Circassia’s Chief Executive, in a prepared statement

The aclidinium bromide/formoterol fumarate therapy is on track to launch in the United States in the second half of 2019, according to Circassia. Its approval is based on a broad clinical database, including data from 3 phase III studies, ACLIFORM, AUGMENT and AMPLIFY.

The drug’s label also includes clinical data from the phase IV ASCENT study, which shows aclidinium therapy is effective at reducing COPD exacerbations. As a result, the product is the only twice-daily LAMA/LABA in the United States with COPD exacerbation data included in its prescribing information, according to Circassia.

“With guidelines recommending combined LAMA and LABA therapy for a number of COPD patient groups, we believe Duaklir® will make an important contribution to the treatment of this debilitating disease,” said Michael Asmus, Circassia’s Vice President, US Medical Affairs, Circassia.

Reference

Circassia Announces FDA Approval of Duaklir® for Maintenance Treatment of Chronic Obstructive Pulmonary Disease [news release]. Oxford, United Kingdom; April 1, 2019: Circassia website. https://www.circassia.com/media/press-releases/circassia-announces-fda-approval-of-duaklir-for-maintenance-treatment-of-chronic-obstructive-pulmonary-disease/. Accessed April 2, 2019.