FDA Approves New COPD Maintenance Treatment

April 24, 2019

DUAKLIR PRESSAIR (aclidinium bromide and formoterol fumarate) provides LAMA/LABA therapy.

Circassia Pharmaceuticals and AstraZeneca collaborated to win regulatory approval of DUAKLIR PRESSAIR (aclidinium bromide and formoterol fumarate) for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

DUAKLIR PRESSAIR is a fixed-dose LAMA/LABA combination of the long-acting muscarinic antagonist (LAMA) aclidinium and the long-acting beta agonist (LABA) formoterol. It is administered twice daily via the pre-loaded, breath-actuated, PRESSAIR multi-dose inhaler. The product is approved worldwide, including in the European Union, under a number of brand names.

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Circassia and AstraZeneca established a commercial collaboration in 2017 in the United States, where Circassia has exclusive U.S. commercialization rights and AstraZeneca is responsible for the product’s development and regulatory submission.

“The FDA approval of DUAKLIR PRESSAIR gives COPD patients a new, effective and safe option in LAMA/LABA therapy, enabling them to receive maximal improvement in lung function delivered through a unique dry-powder inhaler,” said Michael Asmus, Vice President, U.S. Medical Affairs, Circassia.

COPD is the third leading cause of death in the United States; more than 11 million people have been diagnosed with COPD, but millions more may have the disease without knowing it, according to the American Lung Association. COPD causes serious long-term disability and early death, and the number of people dying from COPD is growing.

See more information on clinical trials, indications, safety information, and full prescribing information here.