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.