Auxilium's xiaflex BLA granted priority review

PA-based Auxilium Pharmaceuticals announced today that the FDA has accepted its biologics license application for Xiaflex and granted the submission priority review. Xiaflex is a first-in-class biologic developed for the treatment of Dupuytren's contracture--a condition that causes impairment of the hands. The FDA is expected to make a decision by August 28, 2009.

"We are pleased that the FDA has granted priority review for our Xiaflex BLA. We believe this designation emphasizes the significant need for a non-surgical treatment alternative for Dupuytren's contracture," Armando Anido, CEO and President of Auxilium said in  a statement. "We look forward to working with the FDA as it reviews the application. If approved, we are planning for a U.S. launch approximately 60 days following Xiaflex approval."

- here's the Auxilium release

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