Forest Laboratories, Inc. (FRX) Thursday revealed 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 recommendation will be considered by the FDA but is not binding.
In patients with Chronic Obstructive Pulmonary Disease or COPD, the airways in the lungs typically lose their elasticity, produce excess mucus and become thick and inflamed, limiting the passage of air. The most common symptoms of COPD are breathlessness, abnormal sputum, and a chronic cough.
According to Forest, aclidinium, when given by inhalation, leads to bronchodilation by inhibiting airway smooth muscle contraction.
Forest and Spanish pharma company Almirall are jointly involved in the development of the compound, a novel, long-acting inhaled antimuscarinic agent. Forest and Almirall anticipate receiving FDA feedback on the filing in the second quarter of calendar year 2012.
The companies had announced the FDA submission last June. The submission included efficacy data from a Phase III double-blind placebo-controlled program in which patients received aclidinium bromide 400 mcg or 200 mcg twice daily or placebo.
Aclidinium 400 mcg twice-a-day, the proposed to-be-marketed dose, produced significant improvement in morning trough Forced expiratory volume in 1 second or FEV1 versus placebo at week 12, the primary endpoint assessed as support for the U.S. NDA, and at week 24, which was the primary endpoint assessed in one study as support for a European filing.
ATTAIN (Aclidinium To Treat Airway obstruction In COPD patieNts) was conducted in Europe and South Africa. Aclidinium bromide was administered to patients in the trials using Genuair, a novel, investigational, state-of-the-art multidose dry powder inhaler or MDPI. The Genuair inhaler was designed with a feedback system, which through a 'colored control window' and an audible click helps confirm that the patient has inhaled correctly.
The Advisory 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 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.
An estimated 64 million people have COPD worldwide. Total deaths from COPD are projected to increase by more than 30 percent in the next 10 years without interventions to cut risks, particularly exposure to tobacco smoke.
FRX closed Thursday's regular trade at $32.21, up $0.37 or 1.16%, on the NYSE. In the after-hours, the stock lost $0.07 or 0.22%. Over the past year, the stock traded in a range of $28.47 - $40.52.
by RTT Staff Writer
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