sBLA Submitted for Xiaflex for Peyronie's Disease
Auxilium Pharmaceuticals announced that it has submitted a supplemental Biologics License Application (sBLA) to the FDA for Xiaflex (collagenase clostridium histolyticum or CCH) for the potential treatment of Peyronie's disease (PD). Xiaflex consists of a highly purified combination of two subtypes of collagenase, derived from Clostridium histolyticum, in specific proportion. Together, the collagenase sub-types work synergistically to break the bonds of the triple helix collagen structure more effectively than human collagenase.
The sBLA submission is based on data from the clinical studies known by the acronym IMPRESS – The I nvestigation for M aximal P eyronie's R eduction E fficacy and S afety S tudies – and other controlled and uncontrolled clinical studies, in which over 1,000 Peyronie's disease patients were enrolled and received over 7,400 injections of Xiaflex. In the two Phase 3 double-blind placebo-controlled IMPRESS studies, Xiaflex demonstrated statistically significant improvement in the co-primary endpoints of penile curvature deformity and patient-reported bother vs. placebo. In IMPRESS I at 52 weeks, the co-primary endpoints met statistical significance with a 37.6% mean reduction in penile curvature deformity for Xiaflex subjects (P=0.0005) and a 3.3 point improvement in the Peyronie's Disease Questionnaire (PDQ) bother domain for Xiaflex subjects (P=0.0451). In IMPRESS II at 52 weeks, the co-primary endpoints met statistical significance with a 30.5% mean improvement in penile curvature deformity for Xiaflex subjects (P=0.0059) and a 2.4 point improvement in the PDQ bother domain for Xiaflex subjects (P=0.0496).
Xiaflex for the treatment of PD was granted orphan drug designation in by the FDA in January 1996. Auxilium has requested Priority Review designation for this sBLA submission.
Xiaflex is approved for the treatment of adult Dupuytren's contracture patients with a palpable cord.
For more information call (877) 663-0412 or visit www.auxilium.com.