Auxilium's Xiaflex sBLA FDA-Approved For Dupuytren's Contracture
By Cyndi Root
Auxilium Pharmaceuticals, Inc. announced in a press release that the Food and Drug Administration (FDA) has approved a supplemental Biologics Application (sBLA) for Xiaflex (collagenase clostridium histolyticum or CCH). The collagenase-based treatment was initially approved in 2010 for Dupuytren's disease, excessive collagen deposition that causes contractures of the fingers. The supplemental approval allows for the treatment of up to two Dupuytren's contracture (DC) joints in the same hand during a single treatment visit.
Auxilium shares the success with its partner BioSpecifics. Thomas L. Wegman, President of BioSpecifics, said, "In addition to growth from the expanded label, we also look forward to broadening the commercial reach of Xiaflex into markets outside the U.S. with the potential approval in Japan for Dupuytren's contracture and in the EU for Peyronie's disease. With all of these avenues to reach new patients with Xiaflex, we expect to see continued commercial success through 2015."
Xiaflex
Xiaflex is a combination of two collagenase subtypes derived from Clostridium histolyticum. The agents work together to break the bonds of the triple helix collagen structures that limit finger joint movement. Gary M. Pess, M.D., a hand surgeon from New Jersey, stated that the new label allows him scheduling flexibility and patients more convenience.
The FDA based its approval in part on the Phase III MULTICORD (Multiple Treatment Investigation of Collagenase Optimizing the Resolution of Dupuytren's) trial. That trial and Auxilium's earlier studies (AUX-CC-861 and AUX-CC-864) showed safety and efficacy in the treatment of one hand with multiple affected joints.
Actelion Pharmaceuticals Ltd. markets Xiaflex in Canada, Australia, Mexico, and Brazil. Asahi Kasei Pharma Corporation markets it in Japan. Swedish Orphan Biovitrum AB markets the compound in 71 Eurasian and African countries.
About Auxilium
Auxilium Pharmaceuticals, Inc. was founded in 1999 and is headquartered in Chesterbrook, PA. Its first FDA approval came in 2002 for Testim (testosterone gel) CIII for the treatment of men with low testosterone. In 2013, Auxilium acquired Actient Holdings LLC, advancing its urology product line. In June 2014, the company announced a merger with Canadian biotechnology company QLT Inc., which develops ophthalmology products. QLT remains incorporated in British Columbia, Canada, and is renamed "New Auxilium."