As expected, the FDA has formally approved Auxilium Pharmaceuticals' Xiaflex, the first drug to get a green light to treat Dupuytren's contracture, a crippling buildup of collagen that freezes hands into a clenched position.
Xiaflex is designed to dissolve excess collagen, and in one study, the therapy restored flexibility in the hands of close to half of the patients who had been treated with the drug. An FDA panel unanimously recommended the drug, and Malvern, PA-based Auxilium says it should get it on the market in March. Auxilium (AUXL) plans to field a marketing force of about 100 to sell the drug.
"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 the FDA's Dr. Bob Rappaport. "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."
"We believe the approval of Xiaflex represents a major breakthrough for patients suffering from the debilitating effects of Dupuytren's contracture," says Auxilium CEO Armando Anido. About two weeks ago, Auxilium scored a $15 million milestone from Pfizer, which holds the rights to sell the drug in Europe.
- check out the press release