Auxilium Pharmaceuticals has announced that the 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., E.U., 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 year. It is estimated that 35% to 40% of annual U.S. surgical procedures to treat DC have been performed to treat at least two DC joints at a time.
"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 also will 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."
The sBLA was based on positive results from the global, multicenter phase IIIb Multicord (Multiple Treatment Investigation of Collagenase Optimizing the Resolution of Dupuytren's) trial, together with data from Auxilium's earlier studies (AUX-CC-861 and AUX-CC-864). The Multicord study also examined efficacy and safety of the finger extension procedure at 24, 48 or 72 hours post injection. In phase IIIb clinical trials, two concurrent Xiaflex injections were safely used in the treatment of one hand with multiple affected joints.
"We are pleased with the FDA approval of the sBLA for a labeling expansion for Xiaflex for the treatment of two Dupuytren's joints in the same hand concurrently and the ability to perform the finger extension procedure approximately 24 to 72 hours after injection," said Adrian Adams, CEO and president of Auxilium Pharmaceuticals. "We believe this marks an important milestone for patients and physicians as it expands their options for treating two joints concurrently in one office procedure, which may result in less overall treatment time."
Auxilium also has worked with the FDA to modify the Xiaflex Rems to communicate a change to the wording of the contraindication in patients with a history of hypersensitivity to Xiaflex or other collagenase and to add information related to the risk of skin lacerations in the treated finger or hand of patients with Dupuytren's contracture.