Advisors to the European Medicines Agency have recommended approval of Almirall’s Duaklir, a combination therapy for chronic obstructive pulmonary disease that it is in the process of being sold to AstraZeneca.

The agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Duaklir, which combines Almirall’s already-approved Eklira (aclidinium), a long acting muscarinic antagonist (LAMA), with the long-acting beta-agonist (LABA) formoterol. The twice-daily combo is administered via the Spanish firm’s Genuair dry powder inhaler.

The filing was principally based on two Phase III studies which showed that Duaklir consistently provided significant and sustained improvements in lung function versus placebo. It also demonstrated a statistically significant reduction of 29% in the rate of moderate to severe exacerbations and improved daily symptoms of COPD versus aclidinium and formoterol monotherapies.

In July, AstraZeneca unveiled a deal to buy Almirall’s respiratory drugs in a deal worth up to $2.1 billion, including $875 million upfront. The acquisition is due to complete later this year.