Auxilium Pharmaceuticals, Inc, a specialty biopharmaceutical company, announced that the Arthritis Advisory Committee appointed by the US Food and Drug Administration (FDA) recommended by a unanimous vote of 12 to 0 that Xiaflex (collagenase clostridium histolyticum), a novel, first-in-class, orphan-designated, biologic, be granted marketing approval by the FDA for the treatment of Dupuytren's contracture.
"We are very pleased with the Advisory Committee's unanimous recommendation, which supports our view that Xiaflex has a favourable benefit to risk profile in the treatment of Dupuytren's contracture," said Armando Anido, chief executive officer and president of Auxilium. "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."
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.
Auxilium Pharma, is a specialty biopharmaceutical company with a focus on developing and marketing to urologists, endocrinologists, orthopaedists and select primary care physicians.