CHMP recommendation for Duaklir Genuair for treatment of COPD - AstraZeneca/ Forest Labs/Almirall
Almirall S.A. has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the regulatory approval of Duaklir Genuair (aclidinium bromide/formoterol fumarate) in all EU member states as a maintenance bronchodilator treatment to relieve symptoms in adult patients with Chronic Obstructive Pulmonary Disease (COPD). Aclidinium bromide/formoterol fumarate is a fixed dose combination of two approved long-acting bronchodilators. Aclidinium bromide is a novel anticholinergic or long acting muscarinic antagonist (LAMA). Formoterol fumarate is a long-acting beta-agonist (LABA).
As part of its assessment, CHMP reviewed efficacy and safety data of aclidinium bromide/formoterol fumarate BID from more than 2,000 patients. The clinical program included 11 clinical studies conducted in 29 countries worldwide.
Forest Labs/Actavis have US marketing rights and AstraZeneca have rest of the world rights.
530 mins
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