Merck (NYSE:MRK) has initiated the rolling submission of its U.S. marketing application seeking approval for its vaccine for Ebola Zaire disease, V920 (rVSV∆G-ZEBOV-GP, live attenuated).
V920 has Breakthrough Therapy status which provides for more intensive guidance from the FDA on development, the involvement of more senior agency personnel and a rolling review of the marketing application.
The company expects to complete the filing in 2019.
