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FDA OKs New Fixed-Dose Combination Inhaler for COPD

The US Food and Drug Administration (FDA) has approved a fixed-dose combination of aclidinium bromide 400 μg and formoterol fumarate 12 μg (Duaklir, Circassia Pharmaceuticals) for the maintenance treatment of chronic obstructive pulmonary disease (COPD).

The combination is administered twice daily via the breath-actuated inhaler Pressair (AstraZeneca).

Aclidinium bromide is a long-acting muscarinic antagonist (LAMA) that acts primarily on the M3 receptor to relieve bronchospasm. Formoterol fumarate is a long-acting beta-agonist (LABA) that stimulates B2-receptors, resulting in bronchodilation.

The FDA approval was based on positive results from three Phase 3 studies — ACLIFORM (NCT01462942), AUGMENT (NCT01437397), and AMPLIFY (NCT02796677) — and on the phase 4 ASCENT study (NCT01966107), which specifically showed that the therapy was effective at reducing COPD exacerbations.

“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,” Michael Asmus, Circassia’s vice president, U.S. medical affairs, said in a press release.

“Duaklir’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,” Asmus said.

According to Circassia, Duaklir will be the only twice-daily LAMA/LABA medication in the U.S. with COPD exacerbation data included in its prescribing information.

Steve Harris, chief executive of Circassia, 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 U.S. 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.”

Tudorza is an approved medication to treat COPD symptoms.

In 2017, Circassia established a collaboration with AstraZeneca for the commercialization of Tudorza and Duaklir in the U.S. Since the end of 2018, Circassia has had the full U.S. commercial rights to both therapies.

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