Xiaflex is approved in the US, EU, Canada and Australia to treat adult DC patients with a palpable cord.
Dupuytren’s contracture is a progressive hand disease that can present with multiple collagen cords that limit finger joint movement.
The sBLA was based on positive results from the global, multicenter Phase IIIb MULTICORD trial, together with data from the company’s earlier studies AUX-CC-861 and AUX-CC-864.
The MULTICORD trial also evaluated the efficacy and safety of the finger extension procedure at 24, 48 or 72 hours post injection.
The company said that in Phase IIIb clinical trials, two concurrent Xiaflex injections were safely used to treat one hand with multiple affected joints.
Auxilium Pharmaceuticals chief executive officer and president Adrian Adams said the company is happy 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.
"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," Adams said.