FDA extends review period for Almirall and Forest Labs' aclidinium bromide NDA

Mar 29 2012

Forest Laboratories, Inc. (NYSE:FRX) and Almirall, S.A. (ALM.MC) announced today that the U.S. Food and Drug Administration (FDA) will require a three-month extension to complete its review of the data supporting the New Drug Application (NDA) for aclidinium bromide, a new long-acting antimuscarinic for the maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD). No additional data has been requested by the agency to complete the review. FDA action is now expected by July 2012.

This FDA notification follows the Pulmonary-Allergy Drugs Advisory Committee (PADAC) February 2012 meeting during which the committee endorsed the efficacy and safety of twice-daily aclidinium bromide 400ug with a positive 12 to 2 vote in favor of approval.

The efficacy and safety of aclidinium was studied in a clinical trial program including 2,717 COPD patients in 9 studies. In these trials, aclidinium demonstrated significant improvement in lung function, with a low incidence of side effects, comparable to placebo.