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news.Swedish Orphan Biovitrum (Sobi) has filed for an extension of the label for Xiapex with the European Medicines Agency (EMA) to include the indication of Peyronie's disease.
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Xiapex is the trade name for collagenase clostridium histolyticum (CCH) in the European Union (EU).
Currently, Xiapex is approved to treat Dupuytren’s contracture in adult patients with a palpable cord.
BioSpecifics’ partner, Auxilium Pharmaceuticals is partnered with Sobi for the marketing of Xiapex in 71 Eurasian and African countries to treat Dupuytren’s contracture, and Peyronie’s disease pending applicable regulatory approvals.
The EMA filing is based on positive safety and efficacy outcome data from two double-blind placebo-controlled trial, IMPRESS I and II, which evaluated Xiapex for the treatment of Peyronie’s disease.
The filing follows the approval from the US Food and Drug Administration (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.
The company said that Xiapex is marketed under the tradename Xiaflex in the US.