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 III double-blind placebo-controlled IMPRESS studies, XIAFLEX demonstrated statistically significant improvement in the co-primary endpoints of penile curvature deformity and patient-reported bother versus 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 was generally well-tolerated. The most common treatment related adverse events reported in the phase III studies were local to the treatment site and consistent with adverse events reported in previous PD trials with XIAFLEX, which included injection site hematoma, pain and swelling. Serious adverse events included corporal rupture (penile fracture) in 3 subjects in the placebo controlled studies.
Auxilium Pharmaceuticals, Inc. Submits Supplemental Biologics License Application To The FDA For XIAFLEX® For The Treatment Of Peyronie's Disease
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