sBLA Accepted for Xiaflex for Peyronie's Disease
Auxilium Pharmaceuticals announced that the FDA has accepted for review its supplemental Biologics License Application (sBLA) for Xiaflex (collagenase clostridium histolyticum or CCH) for the treatment of Peyronie's disease (PD). Under the Prescription Drug User Fee Act (PDUFA), an action date is anticipated on September 6, 2013.
Xiaflex consists of a highly purified combination of two subtypes of collagenase, derived from Clostridium histolyticum, in specific proportion. Together, the collagenase sub-types work synergistically to break the bonds of the triple helix collagen structure more effectively than human collagenase.
Xiaflex is currently approved for the treatment of adult Dupuytren's contracture patients with a palpable cord.
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