FDA approves Auxilium's Xiaflex for Peyronie's

Auxilium Pharmaceuticals Inc. (NASDAQ:AUXL) gained $2.31 (12%) to $21.63 on Friday after FDA approved an sBLA for Xiaflex collagenase clostridium to treat Peyronie's disease in adult men who have a plaque that can be felt and a curve in their penis greater than 30 degrees. Xiaflex is the first drug approved by FDA for the indication. The REMS for the injectable form of collagenase was updated to include elements to assure safe use (ETASU) for Peyronie's disease due to the risk of serious adverse events including penile fracture. The label also now includes a boxed warning of the risk. Xiaflex is already approved in the U.S., Canada, Australia and the EU, where it is known as Xiapex, to treat Dupuytren's contracture in adult patients with a palpable cord in the hand. ...