FDA approves first drug for Peyronie's disease

Agency approves Auxlium's Xiaflex for men's sexual disorder

SILVER SPRING, Md. — The Food and Drug Administration has approved a treatment for a sexual deformity that affects men.

The FDA announced the approval of Auxilium Pharmaceuticals' Xiaflex (collagenase clostridium histolyticum), the first drug treatment for Peyronie's disease. Peyronie's disease results from a lump of scar tissue in the penis that causes a curvature of at least 30 degrees during erection, which can make sexual intercourse difficult. Xiaflex received FDA approval in 2010 for Dupuytren's contractor, a progressive hand disease that can affect a person's ability to straighten and properly use their fingers.

"Today's approval expands the available treatment options for men experiencing Peyronie's disease and enables them, in consultation with their doctor, to choose the most appropriate treatment option," FDA Division of Bone, Reproductive and Urologic Products deputy director Audrey Gassman said.


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