4 September 2015 - Alexion Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for its Priority Review of the Company’s Biologics License Application (BLA) for Kanuma (sebelipase alfa), an investigational enzyme replacement therapy for the treatment of lysosomal acid lipase deficiency (LAL-D). The previously disclosed September 8, 2015 PDUFA date has been extended by the standard extension period of three months.

In response to a recent request from the FDA, Alexion submitted additional Chemistry, Manufacturing and Controls (CMC) information. Due to the timing of this submission, the FDA extended the PDUFA date to allow additional time for review of the new information. The FDA has not asked for additional clinical data.

For more details, go to: http://news.alexionpharma.com/press-release/product-news/alexion-receives-notification-pdufa-date-extension-kanuma-sebelipase-alfa