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CAMBRIDGE, England and CAMBRIDGE, Mass. -- Acambis plc (Acambis) announced that its investigational smallpox vaccine ACAM2000 has been designated as a Fast Track product by the U.S. Food and Drug Administration (FDA).
Acambis has delivered 182.5 million doses of ACAM2000 to the U.S. government for its emergency-use Strategic National Stockpile and has orders from several other governments around the world for its investigational smallpox vaccine.
Acambis is currently proceeding toward the submission of a Biologics License Application (BLA) for ACAM2000 based upon data obtained in all ACAM2000 trials conducted, including clinical data from more than 2,900 subjects vaccinated in its phase 3 clinical trials.
Under the FDA Modernization Act of 1997, designation as a Fast Track product for a new drug or biological product means that FDA will take such actions as are appropriate to expedite the marketing application and approval for the product.
Acambis is working with Baxter Healthcare Corporation, part of Baxter International, Inc., to manufacture its investigational ACAM2000 for the United States and other governments, under the FDA's Investigational New Drug application for ACAM2000.
Source: Acambis plc