FDA accepts rolling submission of V 920 in Ebola Zaire disease.- Merck Inc.
Merck Inc. announced that it has started the submission of a rolling Biologics License Application (BLA) to the FDA for V 920 (rVSVG-ZEBOV-GP, live attenuated), the company�s investigational vaccine for Ebola Zaire disease. This rolling submission is made pursuant to the FDA�s Breakthrough Therapy Designation for V920, which was announced by the company in July 2016.
Comment: V920 was initially engineered by scientists from the Public Health Agency of Canada�s National Microbiology Laboratory and subsequently licensed to a subsidiary of NewLink Genetics Corporation. In late 2014, when the Ebola outbreak in western Africa was at its peak, Merck licensed V920 from NewLink Genetics.
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