EU approves Xiapex for Peyronie's disease- Swedish Orphan Biovitrium

Swedish Orphan Biovitrium (Sobi) announced that the EU Commission has approved Xiapex (collagenase clostridium histolyticum) for the treatment of adult men with Peyronie's disease (PD) with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy. PD is a condition that involves the development of collagen plaque, or scar tissue, on the shaft of the penis.

Comment: Xiapex (Xiaflex in the US) is also approved to treat Dupuytrens' Contacture in both the US and EU and offers a pharmacological alternative to complicated surgery. The estimated prevalence of PD in adult men has been reported to be approximately 5%; however the disease is thought to be under-diagnosed and under-treated. It is estimated that between 65,000 and 120,000 PD patients are diagnosed every year,based on U.S.historical medical claims data, but only 5,000 to 6,500 PD patients are treated with injectables or surgery annually.