Forest Laboratories, Inc. (FRX) Thursday announced a 12-2 favorable vote by the U.S. Food and Drug Administration's Pulmonary-Allergy Drugs Advisory Committee for aclidinium bromide for the maintenance treatment of COPD. The recommendations, although not binding, will be considered by the FDA as it completes its review of the NDA for aclidinium bromide.
The Committee was also asked to separately evaluate if the efficacy and safety of the 400 ug twice daily dose had been adequately demonstrated. The members voted unanimously in favor of efficacy and 10 to 3 (1 member abstained) in favor of safety.
Forest and Spanish pharma company Almirall are jointly involved in the development of the compound, a novel, long-acting inhaled antimuscarinic agent.
Forest licensed U.S. rights for aclidinium from Almirall, Kyorin for Japan and Daeowoong for Korea while Almirall maintains rights for the rest of the world.
Forest and Almirall anticipate receiving FDA feedback on the NDA filing in the second quarter of calendar year 2012.
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