Duaklir®* is a fixed dose combination product recently filed for approval in the United States as a treatment for COPD. It contains the long-acting muscarinic antagonist aclidinium bromide and the long-acting beta agonist formoterol fumarate. Duaklir® is presented as a dry powder for inhalation and is delivered via the breath-actuated multi-dose inhaler Pressair®.
Duaklir® was initially approved in the European Union in 2014 and is approved in approximately 50 countries around the world under a number of brand names. In 2017 it completed a phase III clinical study designed to support a regulatory filing in the United States, and our partner AstraZeneca submitted a New Drug Application for the product in Q2 2018.
*The Duaklir® trademark is registered in the United States; the mark is not currently approved for use by the FDA.
Pipeline status: Duaklir® US