Firm plans 2012 sBLA filing with FDA for collagenase Clostridium histolyticum product.
Auxilium Pharmaceuticals reported positive data from its two Phase III studies evaluating Xiaflex® (collagenase Clostridium histolyticum; CCH) in the treatment of Peyronie disease. The Impress I and Impress II studies showed that treatment with Xiaflex led to 37.6% and 30.5% mean reductions in penile curvature deformity, respectively, and 44% and 32.4% improvements in the Peyronie’s Disease Questionnaire (PDQ) bother domain. Auxilium developed the PDQ with FDA as a tool for measuring parameters including bother, severity of phsological and physical symptoms of PD, and penile pain.
Xiaflex is already approved as a treatment for Dupuytren contracture, and Auxilium says it expects to submit an sBLA with FDA for the Peyronie disease indication by the end of 2012. If approved, Xiaflex will be the first biologic therapy available for treating the disorder.
“With its current indication in Dupuytren contracture, positive topline clinical results in Peyronie disease, and development ongoing in frozen shoulder syndrome and cellulite, Xiaflex represents a pipeline in a product with potential applications in multiple therapeutic areas that currently have limited options,” states Adrian Adams Auxilium’s president and CEO.