ARTICLE | Clinical News

Aclidinium bromide/formoterol fumarate regulatory update

September 29, 2014 7:00 AM UTC

EMA's CHMP recommended approval of aclidinium bromide/formoterol fumarate from Almirall as a maintenance bronchodilator to treat symptoms of chronic obstructive pulmonary disease (COPD). Almirall said the product will be marketed under the names Duaklir Genuair and Brimica Genuair in Europe. The product is a fixed-dose combination of a long-acting muscarinic antagonist (LAMA), aclidinium bromide, and a long-acting beta agonist (LABA), formoterol. Almirall expects a final decision from the European Commission within 3 months.

In July, AstraZeneca plc (LSE:AZN; NYSE:AZN, London, U.K.) said it would acquire Almirall's respiratory disease business, including aclidinium bromide/formoterol fumarate, for $875 million up front and up to $1.2 billion in milestones. ...