Auxilium Pharmaceuticals Submits Supplemental Biologics License Application to FDA for XIAFLEX to Treat Peyronie's Disease
Auxilium Pharmaceuticals (NASDAQ: AUXL) today announced that it has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for XIAFLEX® (collagenase clostridium histolyticum or CCH), a novel, in-office, first-in-class biologic therapy for the potential treatment of Peyronie's disease (PD). XIAFLEX for the treatment of PD was granted orphan drug designation in the U.S. by the FDA in January 1996 and, if approved by the FDA, is expected to be the first and only biologic therapy indicated for the treatment of PD. XIAFLEX is currently approved in the U.S., EU and Canada for the treatment of adult Dupuytren's contracture patients with a palpable cord.
"This submission is a significant regulatory milestone for XIAFLEX and Auxilium and further demonstrates our strong commitment to addressing unmet medical needs by potentially providing patients with the only FDA-approved biologic therapy to treat this devastating disease," said Adrian Adams, Chief Executive Officer and President of Auxilium. "PD can have a significant impact on affected men and their partners and we believe that, if approved by the FDA for the treatment of Peyronie's disease, XIAFLEX has the clinical profile