MALVERN, Pa., Nov. 7, 2012 /PRNewswire/ -- Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a specialty biopharmaceutical company, 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 to become a potential breakthrough option in a therapeutic area that currently has limited treatment options. We look forward to working with the FDA as the agency reviews the application."
Auxilium has requested Priority Review designation for this sBLA submission and the Company expects to hear back from the FDA on Priority Review designation within approximately 60 days from the filing date. If granted, the FDA's goal for completing a Priority Review, per Prescription Drug User Fee Act guidelines, is six months from date of receipt. Priority Review may be granted to drugs that offer major advances in treatment, or provide a treatment where none exists.
Check Out Our Best Services for Investors
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Model portfolio
- Stocks trading below $10
- Intraday trade alerts