US FDA Accepts XIAFLEX Supplemental Biologics License Application Filing for Treatment of Peyronie's Disease
Auxilium Pharmaceuticals (NASDAQ: AUXL) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and granted standard review status to its supplemental Biologics License Application (sBLA) for XIAFLEX® (collagenase clostridium histolyticum or CCH), a novel, in-office biologic therapy for the potential treatment of Peyronie's disease (PD). Under the Prescription Drug User Fee Act (PDUFA), the FDA is expected to take action on the application by September 6, 2013.
XIAFLEX is currently approved in the U.S., EU, Canada and Switzerland for the treatment of adult Dupuytren's contracture patients with a palpable cord. XIAFLEX for the treatment of PD was granted orphan 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.
"We are very pleased that XIAFLEX was accepted for review as we believe there is a significant unmet need for a safe and effective treatment with proven results for patients exhibiting the classic penile curvature deformity and patient-reported bother associated with Peyronie's disease," said Adrian Adams, Chief Executive Officer and President of