FDA Advisory Committee Recommends Approval Of Valeant's Brodalumab For Psoriasis

(RTTNews) - Valeant Pharmaceuticals International Inc. (VRX, VRX.TO) Tuesday said the Dermatologic and Ophthalmic Drugs Advisory Committee appointed by the U.S. Food and Drug Administration has voted by a margin of 18 to 0 for the approval of brodalumab injection for adults with moderate-to-severe plaque psoriasis.

The committee's recommendation will be considered by the FDA in its review of the Biologics License Applications (BLA) for brodalumab, a monoclonal antibody that targets the IL-17 receptor.

"The positive recommendation by the FDA's advisory committee represents an important milestone toward our goal of delivering brodalumab to patients who suffer from moderate-to-severe plaque psoriasis," said Joseph Papa, chairman and chief executive officer. "Brodalumab has the potential to improve the lives of many patients suffering from this chronic, debilitating disease, and we greatly appreciated the opportunity to present our body of evidence to the panel. We look forward to working collaboratively with the FDA as it continues its review process."