Auxilium's Xiaflex is approved to treat painful curved penis condition

Auxilium Pharmaceuticals ($AUXL) has nabbed a new indication for its Xiaflex injection. The FDA has approved it for treating Peyronie's disease, which causes a painful curvature of the penis, an indication that may add $100 million in sales in the next 5 years.

On Friday, the FDA said Xiaflex is the first nonsurgical treatment option approved by the agency for treating the condition. It said Peyronie's disease is caused by a lump of plaque that results in a curvature deformity of at least 30 degrees upon erection. According to material in a conference call by Chesterbrook, PA-based Auxilium, between 3% and 9% of men develop the problem, at an average age of 53. An estimated 80% of those have a curvature of 30 degrees or more. Surgery is the standard treatment but has a number of side effects.

But the biologic carries risks to the penis as well, like penile fracture. As a result, the FDA said that if used for Peyronie's disease, Xiaflex will be available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) and administered by trained professionals.

The drug was first approved in 2010 as a treatment for Dupuytren's contracture, a progressive hand disease caused by knots in the connective tissue underneath the skin that can make it difficult to straighten fingers. Swiss-based Actelion Pharmaceuticals ($ATLN) agreed last year to pay Auxilium $10 million up front and about $60 million in milestones for the right to develop and market the drug for that indication. According to Reuters, Cowen and Co. projected that the new approval will boost Xiaflex sales by $100 million by 2018.

- here's the FDA announcement
- more from Reuters