The U.S. Food and Drug Administration (FDA), has approved Xiaflex (Collagenase clostridium histolyticum) to treat a progressive hand disease known as Dupuytren’s contracture.
Dupuytren’s contracture is a painless thickening and contracture of tissue beneath the skin on the palm of the hand and fingers, according to the National Library of Medicine (NLM).
A small, painless nodule develops in the connective tissue on the palm side of the hand and eventually develops into a cord-like band. In severe cases, it’s difficult or even impossible to extend the fingers.
Until now, the only treatment for the disorder was surgery. But, Xiaflex is injected into the cord to weaken and eventually break it.
The agency’s approval of Xiaflex, made by Auxilium Pharmaceuticals, follows a September recommendation made by a panel of outside medical experts, which unanimously voted to support the medication.
An estimated 7 to 14 million Americans are affected by Dupuytren’s disease.
The most common reported adverse reactions are fluid buildup, swelling, bleeding and injection site-pain. While a serious allergic reaction is possible, the agency said, none had been observed during clinical testing.
For more information on Dupuytren’s disease and Xiaflex, please refer to the FDA News Release.