The Food and Drug Administration Tuesday approved the first drug designed to treat a debilitating hand condition known as Dupuytren's contracture. The drug, called Xiaflex, is manufactured by Auxilium Pharmaceuticals Inc. of Malvern, Penn., and the company expects to begin selling it by the end of March. An FDA advisory panel in September unanimously recommended approval of the drug.
Dupuytren's, which affects an estimated 13.5 million to 27 million Caucasians in the United States and Europe, occurs when collagen builds up in the connective tissue in the palm of the hands, forming thick, rope-like cords that hold the fingers in a clenched position. It is most common in men over 50. "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," said Dr. Bob Rappaport of the FDA in a statement. "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."
Xiaflex is a combination of collagen-destroying enzymes isolated from Clostridium histolytica that, when injected into the connective tissue, degrades the excess collagen, restoring flexibility. In one study of 66 patients, 44% had mobility restored, compared to only 5% who received a placebo injection. In a larger study of 306 patients, 64% were treated successfully, compared to only 7% of those who received a placebo.
The most common adverse reactions to Xiaflex were fluid buildup, swelling, bleeding and pain in the injected area. No serious allergic reactions have been observed, but such a response may occur occasionally because the foreign protein could prompt an immune reaction, the FDA said.
Physicians will have to undergo special training in use of the drug before the company will ship it to them, Auxilium officials said. Patients or physicians who have questions can call (877) XIA-FLEX.
-- Thomas H. Maugh II