FDA NEWS RELEASE

For Immediate Release: Dec. 6, 2013 Media Inquiries: Andrea Fischer, 301-796-0393, andrea.fischer@fda.hhs.gov Consumer Inquiries: 888-INFO-FDA

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FDA approves first drug treatment for Peyronies disease

The U.S. Food and Drug Administration today approved a new use for Xiaflex (collagenase clostridium histolyticum) as the first FDA-approved medicine to treat men with bothersome curvature of the penis, a condition known as Peyronies disease.

Xiaflex is the first FDA-approved non-surgical treatment option for men with this condition, who have a plaque (lump) in the penis that results in a curvature deformity of at least 30 degrees upon erection.

Peyronies disease is caused by scar tissue that develops under the skin of the penis. This scar tissue causes an abnormal bend during erection and can cause problems such as bothersome symptoms during intercourse.

Todays approval expands the available treatment options for men experiencing Peyronies disease, and enables them, in consultation with their doctor, to choose the most appropriate treatment option, said Audrey Gassman, M.D., deputy director of the Division of Bone, Reproductive and Urologic Products in the FDAs Center for Drug Evaluation and Research.

Xiaflex is a biologic medicine (made from the protein product of a living organism, collagenase clostridial histolyticum). Xiaflex was first approved by the FDA in 2010 for the treatment of Dupuytrens contracture, a progressive hand disease that can affect a persons ability to straighten and properly use their fingers. Xiaflex is believed to work for Peyronies disease by breaking down the buildup of collagen (a structural protein in connective tissue) that causes the curvature deformity.

A treatment course for Peyronies 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.

The safety and effectiveness of Xiaflex for the treatment of Peyronies disease were established in two randomized double-blind, placebo-controlled studies in 832 men with Peyronies disease with penile curvature deformity of at least 30 degrees. Participants were given up to four treatment cycles of Xiaflex or placebo and were then followed 52 weeks. Xiaflex treatment significantly reduced penile curvature deformity and related bothersome effects compared with placebo.

When prescribed for the treatment of Peyronies disease, Xiaflex is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) because of the risks of serious adverse reactions, including penile fracture (rupture of one of the penile bodies within the penile shaft, also known as corporal rupture) and other serious penile injury. Xiaflex for the treatment of Peyronies disease should be administered by a health care professional who is experienced in the treatment of male urological diseases. The REMS requires participating health care professionals to be certified within the program by enrolling and completing training in the administration of Xiaflex treatment for Peyronies disease. The REMS also requires health care facilities to be certified within the program and ensure that Xiaflex is dispensed only for use by certified health care professionals.

The most common adverse reactions associated with use of Xiaflex for Peyronies disease include penile hematoma, penile swelling and penile pain.

Consumers and health care professionals are encouraged to report adverse reactions from the use of Xiaflex to the FDAs MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 1-800-FDA-1088.

Xiaflex is marketed by Auxilium Pharmaceuticals, Inc., based in Chesterbrook, Pa.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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