Almirall’s aclidinium bromide/formoterol backed by EMA/CHMP to treat COPD

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the regulatory approval of Duaklir Genuair (aclidinium bromide/formoterol fumarate), from Spain's largest pharma company Almirall (ALM: MC), in all European Union member states as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).1

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).2

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.2