View all newsletters
Receive our newsletter – data, insights and analysis delivered to you
  1. Market Data
June 26, 2014

Sobi seeks European approval of Xiapex for Peyronies disease

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.

By Mekala ShivaramPrasad

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.

"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."

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.

Xiapex is a combination of two purified clostridial collagenases for injection that enzymatically disrupts the contracting cord and reduces the contraction.

Sobi 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.

Related Companies

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. A weekly roundup of the latest news and analysis, sent every Friday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU