First Drug Therapy for Peyronie's Disease Approved

The FDA has approved a new indication for Xiaflex (collagenase clostridium histolyticum; Auxilium) for the treatment of Peyronie’s disease, a curvature deformity of the penis due to the presence of a plaque. Xiaflex is the first FDA-approved non-surgical treatment for men with this condition.

The safety and efficacy of Xiaflex for the treatment of Peyronie’s disease were established in two randomized double-blind, placebo-controlled studies in men with Peyronie’s disease (n=832) with penile curvature deformity of >30 degrees. Treatment with Xiaflex significantly reduced penile curvature deformity and related bothersome effects compared to placebo.

A treatment course for Peyronie’s disease consists of a maximum of four treatment cycles. Each treatment cycle consists of two Xiaflex injection procedures (in which Xiaflex is injected directly into the collagen-containing structure of the penis) and one penile modeling procedure performed by the health care professional.

When prescribed for Peyronie’s disease, Xiaflex is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) due to the risks of serious adverse reactions, including penile fracture and other serious penile injury.

First Drug Therapy for Peyronie’s Disease Approved

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