Almirall COPD drug receives CHMP recommendation

Almirall has been granted a recommendation from Europe's Committee for Medicinal Products for Human Use (CHMP) for approval of its chronic obstructive pulmonary disease (COPD) drug Eklira Genuair.

The aclidinium therapy has been endorsed by the European Medicines Agency committee as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD.

This decision was based on a review of safety and efficacy data drawn from more than 2,500 patients, encompassing 26 clinical studies carried out across 26 different nations.

Eklira Genuair is also currently undergoing regulatory assessment in the US, with approvals now expected in both territories later this year.

Bertil Lindmark, chief scientific officer at Almirall, said: "The committee's positive opinion today marks a significant step forward in bringing to prescribers and patients this novel treatment … and validates the strong data supporting aclidinium's efficacy and safety in treating COPD."

Earlier this month, Almirall partner Forest Laboratories published positive new clinical data on linaclotide, an irritable bowel syndrome treatment that Almirall is planning to sell under the name Constella in Europe.