GSK Submits Pandemic Flu Vaccine Under EU Accelerated Review Program
This article was originally published in The Pink Sheet Daily
Executive Summary
Submission marks the first use of the European Medicines Agency’s “core dossier” accelerated review program.
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GlaxoSmithKline Biologicals has submitted the first pandemic flu vaccine marketing authorization application through the European Medicines Agency's "core dossier" program, EMEA announced Jan. 6. The application covers only pandemic use of the vaccine, the agency said. EMEA's Committee for Medicinal Products for Human Use (CHMP) established the core dossier program as a way to more rapidly evaluate flu vaccine applications in case of an avian influenza pandemic (1 (Also see "EMEA Committee Agrees To Expedite Flu Vaccine Reviews" - Pink Sheet, 13 Oct, 2005.)). Under the accelerated process, CHMP reviews the bulk of an application upon submission. Once a strain is identified, the dossier is completed and evaluated within a few days. The vaccine that GSK submitted was derived from the current H5N1 virus as a prototype. The firm would develop a strain-specific vaccine in case of a pandemic. GSK currently markets the flu vaccine Fluarix in the U.S. and the U.K. The program also includes fee waivers for evaluation of core dossiers and scientific advice, EMEA said. -Kathleen Michael |