Xiaflex regulatory update

FDA approved an sBLA from Auxilium for Xiaflex collagenase clostridium histolyticum to treat up to 2 Dupuytren's contracture joints in the same hand during a single treatment visit. The injectable form of collagenase previously was approved for 1 palpable cord. Auxilium said 35-40% of Dupuytren's surgeries are performed on multiple joints. The product is also approved in the U.S. to treat Peyronie's disease and has Orphan Drug status for both indications in the U.S.

The product is also approved in Canada, Australia and the EU, where it is marketed as Xiapex, to treat Dupuytren's contracture in adult patients with a palpable cord. It is under review in Japan to treat Dupuytren's contracture (see BioCentury, Sept. 1). ...