Auxilium Pharmaceuticals, Inc, a specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics Application (sBLA) for Xiaflex (collagenase clostridium histolyticum or CCH) for the treatment of up to two Dupuytren's contracture (DC) joints in the same hand during a single treatment visit.
Xiaflex is a biologic approved in the U.S., EU, Canada and Australia for the treatment of adult DC patients with a palpable cord. DC is a progressive hand disease that can present with multiple collagen "cords" that limit finger joint movement and result in ~70,000 procedures to treat affected patients every year1. It is estimated that 35 to 40 percent of annual U.S. surgical procedures to treat DC have been performed to treat at least two DC joints at a time2.
"In my opinion, Xiaflex provides an effective non-surgical option for treating DC patients with two affected joints concurrently in one office visit," said Gary M. Pess, M.D., an orthopedic hand surgeon with Central Jersey Hand Surgery. "In my practice, the expanded labeling will also allow flexibility in the scheduling process due to the ability to delay the finger manipulation procedure from 24 to up to 72 hours, which may be more convenient for patients."
For more details, got to: http://ir.auxilium.com/phoenix.zhtml?c=142125&p=irol-newsArticle&ID=1979556