Swedish Orphan Biovitrum (Sobi) has filed for an extension of the label for Xiapex (collagenase clostridium histolyticum) with the European Medicines Agency to include the indication of Peyronie’s disease.
The European filing is supported by positive data from the IMPRESS I and IMPRESS II studies (‘The Investigation for Maximal Peyronie’s Reduction Efficacy and Safety Studies’), which evaluated the safety and efficacy of Xiapex in Peyronie’s disease.
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The new filing follows approval from the US Food and Drug Administration in December 2013 of Xiaflex for treatment of adult men with Peyronie’s disease with a palpable plaque and curvature deformity of at least 30° at the start of therapy.
Sobi Partner Products vice-president Anders Edvell said: "We believe that Xiapex, if approved for this new indication, has the clinical profile to make a major contribution to the field in Peyronie’s disease."
Xiaflex is the tradename for Xiapex used in the US. Xiapex received European approval for the treatment of Dupuytren’s contracture in adult patients with a palpable cord.
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Xiapex is a combination of two purified clostridial collagenases for injection that enzymatically disrupts the contracting cord and reduces the contraction.
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By GlobalDataSobi holds the exclusive rights to commercialise Xiapex for Dupuytren’s contracture and Peyronie’s disease indications in 28 EU member countries, as well as Norway and Iceland subject to applicable regulatory approvals.
