FDA approves sBLA for Xiaflex in Dupuytren's Contracture-Auxilium
The FDA has approved the supplemental Biologics License Application (sBLA) submitted by BioSpecifics' partner, Auxilium Pharmaceuticals for Xiaflex (collagenase clostridium histolyticum) for the treatment of up to two Dupuytren's Contracture cords in the same hand during a single treatment visit. The expanded label also allows the ability to delay the finger manipulation procedure from 24 to up to 72 hours.
The sBLA was based on positive results from the global, multicenter Phase IIIb MULTICORD trial, together with data from Auxilium's earlier studies. The MULTICORD study evaluated the use of CCH to treat two Dupuytren's cords concurrently in the same hand with multiple affected joints, and also examined efficacy and safety of the finger extension procedure at 24, 48 or 72 hours post injection. In Phase 3b clinical trials, two concurrent Xiaflex injections were safely used in the treatment of one hand with multiple affected joints.
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