FDA Accepts Merck’s Biologics License Application (BLA) and Grants Priority Review for V920, the Company’s Investigational Vaccine for Ebola Zaire Virus
Merck & Company, Inc. (new) (MRK)
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Source: Business Wire
Merck Continues to Expand Investigational Supply to Support International Ebola Outbreak Response KENILWORTH, N.J.--(BUSINESS WIRE)--Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) and granted priority review for Merck’s investigational Ebola vaccine (V920), under review for the prevention of disease caused by the Ebola Zaire virus. The Prescription Drug User Fee Act (PDUFA), or target action date, is set for March 14, 2020. In July 2016, the FDA granted Breakthrough Therapy Designation to V920.“Merck has worked with government partners and the global health community to accelerate development of our investigational V920 Ebola vaccine. FDA’s priority review designation underscores our long-standing partnership with the U.S. government toward its development and licensure,” said Dr. Paula Annunziato, vice president, Merck Research Laboratories. “A top prio
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