Xiaflex approved for Dupuytren's contracture

XIAFLEX (collagenase clostridium histolyticum) by Auxilium Pharmaceuticals
XIAFLEX (collagenase clostridium histolyticum) by Auxilium Pharmaceuticals

Auxilium Pharmaceuticals announced the approval of Xiaflex (collagenase clostridium histolyticum) for the treatment of adult Dupuytren's contracture patients with a palpable cord. Xiaflex is an orphan-designated, biologic that offers clinicians a nonsurgical medical treatment option for Dupuytren's contracture.

This approval was based on data from two multicenter, randomized, double-blind, placebo-controlled studies in 374 adults with Dupuytren's contracture. The primary endpoint was the proportion of patients who achieved a reduction in contracture of the selected primary joint (metacarpophalangeal joints [MP] or proximal interphalangeal joints [PIP]) to within 0° to 5° of normal, 30 days after the last injection of that joint on Days 30, 60, or 90 (after up to 3 injections). The proportion of patients who achieved a contracture reduction of the primary joint to 0° to 5° after the first injection compared to placebo was 39% versus 1% in Study 1 and 27% versus 5% in Study 2, respectively.   

Xiaflex is expected to be available as a single-use vial in March.

For more information call (877) XIAFLEX or visit www.xiaflex.com.