ARTICLE | Clinical News

Xiaflex collagenase clostridium histolyticum regulatory update

March 3, 2014 8:00 AM UTC

Auxilium said FDA accepted for review an sBLA for Xiaflex collagenase clostridium histolyticum to treat 2 Dupuytren's contracture cords concurrently. The PDUFA date is Oct. 20. The injectable form of collagenase is 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, which affects joints in the hand; and in the U.S. to treat Peyronie's disease in adult men who have a plaque that can be felt and a curve in their penis >=30 degrees. Xiaflex has Orphan Drug status in the U.S. for Peyronie's disease and Dupuytren's contracture. ...