Endo Pharmaceuticals Inc., a subsidiary of Endo International plc announced that the U.S. Food and Drug Administration (FDA) has approved a label update for XIAFLEX® (collagenase clostridium histolyticum or CCH) for the treatment of adult Dupuytren’s contracture (DC) patients with a palpable cord. The updated label now includes a long-term, observational study demonstrating the rate of recurrence for up to 5 years after successful treatment with XIAFLEX®, and the efficacy and safety of retreatment in patients with recurrent DC.
DC is a chronic condition affecting the hand in which abnormal buildup of collagen can cause the fingers to bend and be drawn in toward the palm. It is a rare genetic condition affecting up to 7 percent of adults in the United States.1 An estimated 20 to 60 percent of cases may recur following treatment.
“The FDA’s initial approval of XIAFLEX® more than five years ago brought an effective, non-surgical and minimally-invasive option for the treatment of adult DC patients,” said Sue Hall, Ph.D., Executive Vice President, Chief Scientific Officer and Global Head of Research & Development and Quality at Endo. “Safety and contracture recurrence are important concerns for DC patients and their physicians. The updated label that includes data in patients with recurring contractures coupled with the five-year follow-up data in previously-treated patients further supports the efficacy and safety of XIAFLEX® for initial and retreatment of DC patients."
The long-term, observational study (referred to as Study 4 in the product label) evaluated the recurrence of contracture and safety at Year 2 to Year 5 in patients who had received up to 8 single injections of XIAFLEX® in a previous open-label or double-blind with open-label extension study. A total of 645 patients were enrolled, of whom 30 percent discontinued the study. Recurrence was assessed in successfully treated joints (i.e., a reduction in contracture to 5 degrees or less 30 days after the last injection of XIAFLEX®) and was defined as an increase in joint contracture by at least 20 degree in the presence of a palpable cord, or the joint underwent medical or surgical intervention primarily to correct a new or worsening DC in that joint. Following successful treatment, the probability of remaining recurrence free was 80 percent at Year 2 and 50 percent at Year 5.
The second study (referred to as Study 5 in the product label) evaluated a subset of patients from Study 4 for a joint that was previously successfully treated but had recurrence. Patients in this study received up to 3 injections of XIAFLEX®. Of the 91 patients eligible for the study, 52 enrolled. In the study, 65 percent of recurrence in the metacarpophalangeal (MP) joints (i.e., the knuckle between the hand and the finger) and 45 percent of recurrence in the proximal interphalangeal (PIP) joints (i.e., middle joint of a finger) achieved clinical success after retreatment. No new safety signals were identified among subjects who were retreated with XIAFLEX®.
Source: Endo Pharmaceuticals Inc