Duaklir® US

Duaklir® is a fixed dose combination product recently approved 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®.

Product progress

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, which was submitted in Q2 2018. The product was subsequently approved in the US in March 2019 and launch is planned for H2 2019.