FDA Accepts sBLA for Xiaflex for Concurrent Treatment of Multiple Palpable Cords

Auxilium announced that the FDA has accepted its supplemental Biologics License Application (sBLA) for the use of Xiaflex (collagenase clostridium histolyticum, or CCH) for the treatment of two Dupuytren’s contracture (DC) cords concurrently.

The sBLA submission is based on positive results from the global, multicenter Phase 3b MULTICORD (Multiple Treatment Investigation of Collagenase Optimizing the Resolution of Dupuytren’s) trial, together with data from earlier studies (AUX-CC-861 and AUX-CC-864). The study also examined efficacy and safety of the finger extension procedure at 24, 48 or 72 hours post injection.

XIAFLEX is already approved for the treatment of Dupuytren’s contracture in patients with a palpable cord and for the treatment of adult men with Peyronie’s disease with a palpable plaque and a curvature deformity of at least 30 degrees at the start of therapy.

Xiaflex is also currently being studied in Phase 2 clinical trials in the following collagen-related conditions: frozen shoulder syndrome, cellulite, and lipoma.

Want to read more?