SOBI files Xiapex at EU to treat Peyronie's disease.
Swedish Orphan Biovitrum AB (Sobi) and Auxilium Pharmaceuticals, Inc. have announced that Sobi has filed for an extension of the label for Xiapex (collagenase clostridium histolyticum) with the European Medicines Agency (EMA) to include the indication of Peyronie's disease.
The filing is based on positive safety and efficacy outcome data from two double-blind placebo-controlled studies,IMPRESS I and II (The Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies) which evaluated Xiapex for the treatment of Peyronie's disease. The EMA filing follows the approval from the FDA in December 2013 of Xiaflex for the treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy. Xiaflex is the tradename for Xiapex used in the United States.
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