Xiapex approved by the EU Commission for the treatment of Peyronie's disease

03-Feb-2015 - Sweden

Swedish Orphan Biovitrum AB (publ) (Sobi) announced that the EU Commission has approved 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.  Peyronie's disease is a condition that involves the development of collagen plaque, or scar tissue, on the shaft of the penis.

Xiapex was approved in December 2013 by the Food and Drug Administration (FDA) in the United States for the treatment of Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy. Xiaflex® (collagenase clostridium histolyticum) is the trade name for Xiapex used in the United States.

Xiapex is also approved in the European Union (EU) for the treatment of Dupuytren's contracture in adult patients with a palpable cord. In 2013 Sobi and Auxillium Pharmaceuticals Inc. signed an agreement giving Sobi the exclusive rights to commercialise Xiapex  for the treatment of Dupuytren's contracture and Peyronie's disease in 71 Eurasian and African countries. Sobi is Marketing Authorisation Holder (MAH) for Xiapex in the 28 EU Member States, as well as Norway and Iceland.

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