FDA approves Xiaflex for debilitating hand condition

Xiaflex has recently been approved to treat progressive hand disease Dupuytren's contracture, which can affect a person’s ability to straighten and use their fingers.

Dupuytren's contracture affects the connective tissue found beneath the skin in the palm of the hand. An excess of 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 (collagenase clostridium histolyticum) 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. Xiaflex is the first drug to be approved to treat Dupuytren's contracture.

‘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 of a risk of tendon ruptures. The most common adverse reactions in patients treated with Xiaflex were fluid build up, swelling, bleeding and pain in the injected area.

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

Xiaflex is manufactured by Auxilium Pharmaceuticals, a biopharmaceutical company based in Malvern, Pennsylvania.

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