Auxilium Pharm Says Sobi Files For EU Approval Of Xiapex For Peyronies Disease

(RTTNews) - Auxilium Pharmaceuticals Inc. (AUXL) said that specialty healthcare company Swedish Orphan Biovitrum AB (SWTUY.PK), or Sobi has filed for an extension of the label for Xiapex (collagenase clostridium histolyticum) with the European Medicines Agency or EMA to include the indication of Peyronie's disease.

Xiapex is approved in Europe for the treatment of Dupuytren's contracture in adult patients with a palpable cord. Sobi is Marketing Authorisation Holder (MAH) for Xiapex in 28 EU member countries as well as Norway and Iceland. Sobi holds the exclusive rights to commercialise Xiapex for Dupuytren's contracture and Peyronie's disease indications in these countries subject to applicable regulatory approvals.

Peyronie's Disease is a condition that involves the development of collagen plaque, or scar tissue, on the shaft of the penis. The scar tissue, known as a Peyronie's plaque, may harden and reduce flexibility, which may cause bending or arching of the penis during erection.