FDA Advisory Committee recommends aclidium bromide(Forest/Almirall) for COPD

Forest Laboratories, Inc. and Almirall, S.A. announced that the FDA Pulmonary-Allergy Drugs Advisory Committee voted 12 to 2 in favor of approving the New Drug Application (NDA) for aclidinium bromide, a new long-acting antimuscarinic for the maintenance treatment of COPD. 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.Aclidinium bromide is a novel, long-acting inhaled antimuscarinic agent, which is often referred to as an anticholinergic that has a long residence time at M3 receptors and a shorter residence time at M2 receptors. When given by inhalation, aclidinium leads to bronchodilation by inhibiting airway smooth muscle contraction. Forest Laboratories, Inc. 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. Almirall and Forest are jointly involved in the development of the compound.Almirall has filed the drug in the EU.Proposed names for the drug are Eklira and in USA and Bretairis in the EU.