ROCKVILLE, Md. The Food and Drug Administration has approved a drug for treating a debilitating hand condition which affects an estimated 13.5 million to 27 million Caucasians in the United States and Europe, the agency announced Tuesday.
The FDA approved Xiaflex (collagenase clostridium histolyticum), made by Malvern, Pa.-based Auxilium Pharmaceuticals. The drug is used to treat Dupuytren’s contracture, which causes collagen to build up in the connective tissue beneath the skin in the palm of the hand, forming rope-like cords of tissue that can prevent the fingers from being able to relax and straighten normally.
The drug, an injectable biologic, works by breaking down the excess 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,” FDA Center for Drug Evaluation and Research director for anesthesiology, analgesia and rheumatology Bob Rappaport said. “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.”