FRAMINGHAM, Mass.--(BUSINESS WIRE)--GTC Biotherapeutics, Inc. (“GTC”)(Nasdaq:GTCB) announced today that the US Food and Drug Administration, or FDA, has designated ATryn® a “fast track product” entitled to accelerated FDA review for the hereditary antithrombin deficiency indication. The FDA has also granted GTC permission to submit the associated Biologics License Application, or BLA, for ATryn® on a rolling basis. Fast track designation is provided to those products that are intended to treat serious or potentially life threatening conditions for which there is an unmet medical need. The BLA requesting marketing approval for ATryn® will be submitted as sections are completed rather than waiting for all sections to be submitted together, enabling FDA review to begin sooner. GTC anticipates filing the initial sections with the FDA in the fourth quarter and completing the rolling submission after all clinical data is gathered, analyzed, and available for the BLA, which is planned to be by the end of the first quarter of 2008.
