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FDA Approves Xiaflex for Debilitating Hand Condition
Date:2/2/2010

SILVER SPRING, Md., Feb. 2 /PRNewswire-USNewswire/ -- 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.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

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.


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SOURCE U.S. Food and Drug Administration
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