FDAnews Drug Daily Bulletin

FDA Approves Xiaflex for Peyronie’s Disease

Dec. 10, 2013

The FDA has approved Auxilium Pharmaceuticals’ Xiaflex biologic injection for Peyronie’s disease, a deformity of the penis caused by a lump of plaque that results in a curvature of at least 30 degrees. The drug represents the first non-surgical treatment option for men with the disease.

The decision was based on data from two randomized, double-blind and placebo-controlled trials of 832 men that showed that Xiaflex (collagenase clostridial histolyticum) significantly reduced curvature and symptoms associated with it.

The treatment consists of four cycles, each with two injections directly into the lump and a modeling procedure. Its approval comes with a strict REMS program; injection must be administered by a healthcare professional certified to inject it at a facility certified to dispense it.

The drug was first approved by the FDA in 2010 for Dupuytren’s contracture. — Lena Freund

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