Merck Begins Rolling Submission of Licensure Application for V920 to USFDA

Merck, known as MSD outside the United States and Canada, announced that it has started the submission of a rolling Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for V920 (rVSV∆G-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. “By the FDA agreeing to accept our BLA on a rolling basis, we have together made another important step forward in accelerating the regulatory review process for V920,” said Paula Annunziato, M.D., vice president for clinical research, Merck Research Laboratories. “We are fully committed to the development of this important vaccine against Ebola. In the meantime, pre-licensure, investigational doses of V920 are available to support response to Ebola Zaire outbreaks on an emergency basis in coordination with global public health authorities.” Currently, Merck expects the rolling submission of the BLA to be completed in 2019. – Medical Buyer Bureau