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FDA NEWS RELEASE

For Immediate Release: Feb. 2, 2010
Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

 

FDA Approves Xiaflex for Debilitating Hand Condition

 

The U.S. Food and Drug Administration today approved Xiaflex (collagenase clostridium histolyticum) as the first drug to treat a progressive hand disease known as Dupuytren's contracture, which can affect a person’s ability to straighten and properly use their fingers.

Dupuytren's contracture affects the connective tissue found beneath the skin in the palm of the hand. Too much collagen can build up, forming thick, rope-like cords of tissue that can prevent the fingers from being able to relax and straighten normally. The disorder is most common in Caucasians and in men over age 50.

Xiaflex is a biologic drug made from the protein product of a living organism. It works by breaking down the excessive buildup of collagen in the hand.

"Before the FDA approved Xiaflex, the only effective treatment for this hand disorder was surgery, which sometimes meant a long recovery and the need for physical therapy for patients. Since there are no other non-surgical alternatives for Dupuytren’s contracture, Xiaflex will be an important advance in the management of this disabling condition," said Bob Rappaport, M.D., director, Division of Anesthesiology, Analgesia, and Rheumatology of the FDA’s Center for Drug Evaluation and Research.

Xiaflex is injected directly into the collagen cord of the hand and should be administered only by a health care professional experienced with injections of the hand, because tendon ruptures may occur.

The most common adverse reactions in patients treated with Xiaflex were fluid build up, swelling, bleeding, and pain in the injected area. Although no serious allergic reactions have been observed, such a response would not be unexpected because this foreign protein could prompt an immune system reaction.

In one 66-patient study, 44 percent of those injected with Xiaflex were treated successfully, compared to 5 percent for patients who received a placebo. In a separate 306-patient study, 64 percent of patients given Xiaflex were treated successfully, compared to only 7 percent of patients receiving the placebo.

Xiaflex is manufactured by Auxilium Pharmaceuticals Inc., a specialty biopharmaceutical company based in Malvern, Penn.

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