Auxilium Pharmaceuticals, a biopharmaceutical company, has obtained an approval from the US Food and Drug Administration (FDA) for Xiaflex (collagenase clostridium histolyticum) for the treatment of Peyronie's disease.
The company claims that Xiaflex is the first and only FDA-approved treatment proven effective for Peyronie's disease in men with a palpable plaque and a curvature deformity of 30 degrees or greater at the start of therapy.
FDA has approved Xiaflex based on the favorable safety and efficacy data from the pivotal IMPRESS (The Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies) trials, the Phase III double-blinded placebo-controlled studies that assessed Xiaflex for the treatment of Peyronie's disease.
In IMPRESS I and IMPRESS II at 52 weeks, both co-primary endpoints met statistical significance for mean percent change in penile curvature deformity and mean change in the PDQ bother domain score for Xiaflex subjects compared to placebo patients.
Auxilium Pharmaceuticals president and CEO Adrian Adams noted the company is delighted about the FDA approval of XIAFLEX for Peyronie's disease and the company believes it is well prepared for commercialization of this important new indication.
"We believe that this milestone, along with other recent additions to our urology portfolio, anchors our position as a leading company in the men's healthcare area.
"We are proud of the strength of what is an increasingly more diversified portfolio of products, which covers treatments for low testosterone, erectile dysfunction, and now Peyronie's disease and we feel that this positions us well for future potential growth and shareholder value creation," Adams added.
Xiaflex has also obtained approval in the US, the EU, Canada and Australia for the treatment of adult Dupuytren's contracture (DC) patients with a palpable cord. In the EU, the drug is marketed under the trade name Xiapex.
Auxilium Pharmaceuticals has Auxilium Advantage to support access to Xiaflex. Auxilium Advantage is intended to provide a single point of contact for health care providers and patients for help accessing the product.
Peyronie's disease is a condition where collagen plaque (Peyronie's plaque), or scar tissue, develops on the shaft of the penis. This plaque may harden and reduce flexibility, which may cause bending or arching of the penis during erection.
