Sobi's Xiapex receives positive opinion by CHMP for the treatment of Peyronie's disease

23-Dec-2014 - Sweden

Swedish Orphan Biovitrum AB and partner Auxilium Pharmaceuticals, Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the use of Xiapex® (collagenase clostridium histolyticum) 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.

The use of Xiapex in men with Peyronie's disease is supported by positive safety and efficacy outcome data from two double-blind placebo-controlled studies IMPRESS I and II (Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies).

In December 2013, the United States Food and Drug Administration (FDA) approved Xiaflex® (collagenase clostridium histolyticum) 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 trade name for Xiapex used in the United States.

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