Circassia Pharma announced the FDA approved Duaklir Pressair for the maintenance treatment of chronic obstructive pulmonary disease (COPD). Pressair is an AstraZeneca inhaler. The FDA approved Duaklir earlier this month for the same indication.
The Duaklir approval was based on data from three Phase III clinical trials, ACLIFORM, AUGMENT and AMPLIFY. It also included clinical data from the Phase IV ASCENT trial, which demonstrated aclidinium therapy is effective at reducing COPD exacerbations.
The approval of Duaklir Pressair was based on the AMPLIFY trial data. The trial compared the efficacy and safety of inhaled Duaklir Pressair to its individual ingredients, aclidinium and formoterol, and to Boehringer Ingelheim’s inhaled Spiriva Handihaler (tiotropium) in 1,583 patients with moderate-to-very-severe symptomatic COPD. Duaklir Pressair significantly improved lung function compared to aclidinium using several different metrics. It also showed numerical improvements in overall early-morning symptom severity score compared to Spiriva Handihaler.
COPD (chronic obstructive pulmonary disease) is a progressive disease associated mainly with tobacco smoking, air pollution or occupational exposure, which makes it hard to breathe and results in increased episodes of breathlessness. According to the American Lung Association, COPD is the third leading cause of death in the United States. More than 11 million people have been diagnosed with COPD.
About Duaklir Pressair
Duaklir is a fixed-dose combination treatment of the long-acting muscarinic antagonist (LAMA) aclidinium bromide and long-acting beta-agonist (LABA) formoterol fumarate. It is administered twice-daily by way of the breath-actuated inhaler Pressair.
Circassia and AstraZeneca entered into a collaboration agreement in April 2017, with Circassia gaining exclusive U.S. commercialization rights to Duaklir Pressair, while AstraZeneca was responsible for the product’s development and regulatory submission.Source: Businesswire