Auxilium announced that the Food and Drug Administration (FDA) has approved a supplemental Biologics Application (sBLA) for Xiaflex (collagenase clostridium histolyticum) for the treatment of up to two Dupuytren’s contracture joints in the same hand during a single treatment visit.
The expanded approval was based on data from the MULTICORD trial, a global, multicenter Phase 3b study, along with data from the AUX-CC-861 and AUX-CC-864 studies. The MULTICORD trial also studied efficacy and safety of the finger extension procedure at 24, 48, and 72 hours post-injection. The study demonstrated that 2 injections were safely used in the treatment of one hand with multiple affected joints.
Also, the Xiaflex REMS will be modified to reflect a change in the contraindication section with the addition of information related to the risk of skin lacerations in the treated finger or hand of patients with Dupuytren’s contracture.
Xiaflex is a biologic that is already approved for the treatment of adult Dupuytren’s contracture patients with a palpable cord, and for the treatment of adult males with Peyronie’s disease with a palpable plaque and penile curvature deformity of >30 degrees.
For more information call (877) 633-0412 or visit Xiaflex.com.