Merck Gets FDA Breakthrough Status for Ebola VaccineBy
Merck & Co. Inc. has received breakthrough therapy designation for V920 (rVSVâˆ†G-ZEBOV-GP, live attenuated), its investigational vaccine for Ebola Zaire, from the US Food and Drug Administration (FDA) and has been granted priority medicine (PRIME) status by the European Medicines Agency (EMA). The FDA's breakthrough therapy designation is intended to expedite development and FDA review. PRIME is intended to optimize development plans and speed up assessment of the medicine's application in the European Union.
V920 was initially engineered by the Public Health Agency of Canada's National Microbiology Laboratory and then licensed to a subsidiary of NewLink Genetics, an Ames, Iowa-based biopharmaceutical company. Merck licensed V920 from NewLink Genetics in late 2014 and has since worked with NewLink Genetics and a number of external collaborators on a broad clinical development program with funding from the US government.
Merck is responsible for the research, development, manufacturing, and regulatory efforts in support of V920. The company is working closely with other stakeholders to accelerate the continued development, production and, if licensed, distribution of the vaccine.
Source: Merck & Co. Inc.