Almirall’s aclidinium bromide/formoterol fumarate recommended for approval in Europe to treat COPD

Almirall S.A. (ALM) announced today 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).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

“We are very pleased with the CHMP positive recommendation for aclidinium bromide/formoterol fumarate” said Thomas Eichholtz, Chief Scientific Officer at Almirall. “The Committee’s positive opinion today marks a significant step forward in bringing this new treatment option to patients with COPD.”

In the EU, the European Commission generally follows the recommendations of the CHMP (EMA) and delivers its final decision within three months after the CHMP recommendation. The decision will be applicable to all 28 EU member states plus Iceland and Norway. Aclidinium bromide/formoterol fumarate will be marketed in Europe by Almirall under the trade name Duaklir^® Genuair^® and Brimica^® Genuair^®.

Almirall’s respiratory franchise is complemented by aclidinium bromide, a long-acting inhaled muscarinic receptor antagonist (LAMA) for COPD. Aclidinium bromide was approved by the EMA and by the US Food and Drug Administration (FDA) in 2012 and is available in in 24 countries marketed under the trade names Eklira^® Genuair^®, Bretaris^® Genuair^®, Tudorza™ Pressair™ and Tudorza™ Genuair™. Further compounds in development include abediterol, a novel long acting beta-2 adrenergic agonist (LABA) for asthma and COPD, two novel dual action long-acting muscarinic antagonist beta-2 agonist MABA compounds plus PAN-JAK and PI3Kδ inhibitors.

1. European Medicines Agency. Aclidinium bromide/formoterol fumarate CHMP opinion. Available at: http://www.ema.europa.eu/ema/
2. Aclidinium bromide/formoterol fumarate Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/