Circassia’s Duaklir Approved by FDA for Maintenance Treatment of COPD

Circassia announced that the U.S. Food and Drug Administration (FDA) approved its medication Duaklir for the maintenance treatment of chronic obstructive pulmonary disease (COPD). The company plans to launch the therapy in the United States in the second half of 2019.

Duaklir is a combination of two long-acting bronchodilators: aclidinium bromide (400 mcg) and formoterol fumarate (12 mcg). It is administered twice daily, via the Pressair inhaler, a plastic device which automatically delivers the medication upon inhalation.

The two bronchodilators increase the caliber of the airways by relaxing smooth muscle tone.

Smooth muscle is a type of muscle that surrounds the airways, and that is not under voluntary control. It is regulated by sympathetic and parasympathetic nerves — parasympathetic nerves, acting through muscarinic receptors, constrict it, whereas sympathetic nerves, acting through beta-adrenergic receptors, relax it.

Aclidinium bromide is a long-acting muscarinic antagonist (LAMA); it blocks muscarinic receptors, thereby preventing airway constriction. Formoterol fumarate is a long-acting beta agonist (LABA); it activates beta-adrenergic receptors, thereby promoting airway relaxation.

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.