The U. S. Food and Drug Administration, has approved the circulation of Auxilium Pharmaceuticals Inc.'s Xiaflex injection to treat a hand disease called Dupuytren's Contracture. It is a disorder caused by the buildup of an abnormal amount of collagen in hands. The collagen builds nodules in the palm of the hand, which eventually forms an internal rope-like cord into the fingers making them bent and difficult to extend.
The approval led to a 10% hike in Xiaflex's extended trading.
"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, Director of the Division of Anesthesiology, Analgesia, and Rheumatology of the FDA's Center for Drug Evaluation and Research.
One of the main studies submitted for approval of Xiaflex, examined 306 patients. Out of them, 203 patients were given Xiaflex injections and 103 were given a placebo or non-drug injections.
The study concluded that 64% of the patients in the Xiaflex group achieved clinical success whereas in the placebo group, the rate remained to be 7%. About 85% of patients in the Xiaflex group witnessed 50% improvement in finger flexibility.
Common side effects of the drug in clinical trials were found to be fluid buildup, swelling and pain and bruising in the injected area.
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