Swedish Orphan Biovitrum AB (Sobi) and Auxilium Pharmaceuticals, Inc, announced that Sobi has filed for an extension of the label for Xiapex (collagenase clostridium histolyticum) with the European Medicines Agency (EMA) to include the indication of Peyronie's disease.
The filing is based on positive safety and efficacy outcome data from two double-blind placebo-controlled studies, IMPRESS I and II (The Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies) which evaluated Xiapex for the treatment of Peyronie's disease. The EMA filing follows the approval from the United States Food and Drug Administration (US FDA) in December 2013 of Xiaflex (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. Xiaflex is the tradename for Xiapex used in the United States.
"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," says Anders Edvell, MD, PhD, vice president Sobi Partner Products.
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.