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.