FDA panel recommends Auxilium's Dupuytren's contracture drug

Auxilium Pharmaceuticals, a specialty biopharmaceutical company, has reported that the arthritis advisory committee appointed by the FDA recommended by a unanimous vote of 12 to zero that Xiaflex, a novel, first-in-class, orphan-designated, biologic, be granted marketing approval by the FDA for the treatment of Dupuytren's contracture.

The advisory committee's recommendation, although not binding, will be considered by the FDA in its review of the biologics license application that Auxilium has submitted for Xiaflex.

The original target Prescription Drug User Fee (PDUFA) action date for the FDA's decision as to whether to grant marketing approval for Xiaflex was August 28, 2009. The FDA has not updated the target PDUFA action date.

Armando Anido, CEO and president of Auxilium, said: "We are very pleased with the advisory committee's unanimous recommendation, which supports our view that Xiaflex has a favorable benefit to risk profile in the treatment of Dupuytren's contracture.

"Xiaflex has the potential to provide an important new non-surgical treatment option for patients with Dupuytren's contracture, a debilitating hand condition severely affecting patients' quality of life."

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