US FDA delays approval of Almirall and Forest Laboratories' COPD drug

The US Food and Drug Administration has said it will require a three-month extension to complete its review of the data supporting the New Drug Application for aclidinium bromide, a new long-acting antimuscarinic for the maintenance treatment of chronic obstructive pulmonary disease (COPD) from Spanish drugmaker Almirall (ALM.MC) and USA-based partner Forest Laboratories (NYSE:FRX).

No additional data has been requested by the agency to complete the review. The FDA action is now expected by July 2012. This FDA notification follows the Pulmonary-Allergy Drugs Advisory Committee (PADAC) meeting earlier this year, in which the committee endorsed the efficacy and safety of twice-daily aclidinium bromide 400mcg with a positive 12 to two vote in favor of approval (The Pharma Letter February 24). Brand-named Eklira by Almirall, Spain’s largest pharma company, if approved, Forest has proposed marketing the drug under the name Tudorza Pressair.

The efficacy and safety of aclidinium was studied in a clinical trial program including 2,717 COPD patients in nine studies. In these trials, aclidinium demonstrated significant improvement in lung function and symptoms, with a low incidence of side effects, comparable to placebo. Aclidinium was also submitted to EMA for approval in July 2011. The regulatory process in on track and response is expected during 2012.