Auxilium Pharmaceuticals won the unanimous backing of an FDA advisory panel for its experimental therapy to treat Dupuytren's contracture. The panel said that Xiaflex is a safe and effective alternative to surgery as a treatment for a condition that afflicts the connective tissue in the hand. Trading in Auxilium's shares had been halted ahead of the vote.
Some seven million to 14 million people suffer from Dupuytren's disease, a buildup of collagen that leaves fingers bent, with patients unable to extend them normally. Surgery has been the only therapy available. The FDA doesn't have to follow the advice of its expert panels, but it usually does. And a unanimous vote would be hard to overlook.
"We are very pleased with the advisory committee's recommendation," said Armando Anido, Auxilium's chief executive. "Xiaflex has the potential to provide an important new nonsurgical treatment option for patients with Dupuytren's contracture, a debilitating hand condition severely affecting patients' quality of life."