FDA Approves Aclidinium Bromide/Formoterol Fumarate for COPD Maintenance

The US Food and Drug Administration (FDA) has approved fixed-dose combination aclidinium bromide/formoterol fumarate (Duaklir) for the maintenance treatment of chronic obstructive pulmonary disease (COPD).

The Circassia Pharmaceuticals and AstraZeneca collaborative 400 mcg/12 mcg combination therapy was approved for twice-daily administration via the breath-actuated Pressair inhaler in patients with COPD. It provides a combination of long-acting muscarinic antagonist (LAMA) aclidinium bromide and long-acting beta-agonist (LABA) formoterol fumarate to help reduce COPD exacerbations.

The therapy gained approved on the support of a trio of phase 3 studies (ACLIFORM, AUGMENT, and AMPLIFY), as well as the phase 4 ASCENT COPD trial—in which it was shown to effectively reduce patient exacerbations.

At the 2018 American Thoracic Society Annual Meeting in San Diego, CA, last May, investigators reported that, in the 3589-patient ASCENT COPD trial, there were no increased risk of major adverse cardiovascular events (MACE) or other serious cardiovascular events in patients treated with aclidinium versus those on placebo. Treated patients also reported a 22% reduction in moderate to severe exacerbations versus placebo patients (P < .001), and a 35% reduction in hospitalizations (P < .01) due to COPD exacerbation during their first year of care.

Circassia Vice President of US Medical Affairs Michael Asmus expressed excitement for Duaklir’s impeding role in the COPD management market.

“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,” Asmus said in a statement. “Dukalir’s approval is based on a broad clinical database, including data demonstrating a reduction in the risk of COPD exacerbations driven by its aclidinium component, and we look forward to making this new therapeutic option available to patients across the United States.”

Circassia had acquired the rights to the therapy in the US from AstraZeneca in 2017, and must now pay a $20 million contingent option fee to the selling company within 30 days of the approval, and another deferred $100 million by the end of June.

The pharmaceutical company expressed intent to launch the therapy in the US in the second half of 2019.