FDA approves Duaklir inhaler for maintenance treatment of COPD

The U.S. Food and Drug Administration (FDA) has approved Duaklir Pressair (aclidinium bromide, formoterol fumarate) for the maintenance treatment of chronic obstructive pulmonary disease (COPD).

FDA has granted approval to Pharma company Circassia who is planning to is launch Duaklir® in the United States in the second half of 2019 via its dedicated COPD sales force.

Duaklir Pressair combines aclidinium bromide, a long-acting muscarinic antagonist (LAMA), and formoterol fumarate, a long-acting beta₂-adrenergic agonist (LABA). It is intended for twice-daily use with the breath-actuated Pressair inhaler.

Steve Harris, Circassia’s Chief Executive, said: “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 was supported by data from the phase 3 ACLIFORM, AUGMENT, and AMPLIFY studies which included patients with moderate to very severe COPD. The 24-week trials evaluated the efficacy of Duaklir Pressair compared with aclidinium 400mcg, or formoterol fumarate 12mcg in nearly 5000 patients aged >40 years.

Results showed that treatment with Duaklir Pressair led to a statistically significant increase in mean change from baseline in trough FEV₁ and change from baseline in 1-hour post-dose FEV₁ at week 24 (co-primary endpoints) relative to formoterol fumarate 12mcg and aclidinium 400mcg, respectively.

In addition, the labeling includes results from the phase 4 ASCENT study (N=3630) which evaluated aclidinium bromide in patients with moderate to very severe COPD with and without a history of exacerbations. The primary endpoint was rate of moderate to severe exacerbations during the first year of treatment, defined as worsening of COPD symptoms for at least 2 consecutive days that required treatment with antibiotics and/or systemic corticosteroids or resulted in hospitalization or death. The data showed aclidinium bromide statistically significantly reduced COPD exacerbations by 17% vs placebo (P=.003).

“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,” stated Michael Asmus, Circassia’s Vice President, US Medical Affairs.

Duaklir is anticipated to launch in the second half of this year as a 400mcg/12mcg strength dry powder inhaler containing 30- or 60-metered doses.