Xiaflex Label Updated With Contracture Recurrence Data
Endo announced that the Food and Drug Administration (FDA) has approved a label update for Xiaflex (collagenase clostridium histolyticum) for the treatment of adult Dupuytren's contracture (DC) patients with a palpable cord.
The label now includes data from a long-term, observational study showing the rate of recurrence for up to five years after successful treatment with Xiaflex, as well as the efficacy and safety of retreatment in patients with recurring DC.
Study 4 examined the recurrence of contracture and safety at Year 2 to 5 in patients who had received up to eight single injections of Xiaflex in a previous open-label or double-blind with open-label extension study (n=645). Data showed that after successful treatment, the probability of remaining recurrence free was 80% at Year 2 and 50% at Year 5.
Study 5 examine a subset of patients from Study 4 for a joint that was previously successfully treated but had recurrence (n=52). Data showed that 65% of recurrence in the metacarpophalangeal (MP) joints and 45% recurrence in the proximal interphalangeal (PIP) joints obtained clinical success after retreatment. Also, no new safety signals were found among the retreated patients.
Xiaflex is a biologic currently approved for adults with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy, and for the treatment of adult DC patients with a palpable cord.
For more information call (877) 942-3539 or visit Xiaflex.com.