- Merck (MRK -0.4%) announces that its experimental Ebola vaccine, V920 (rVSVdeltaG-ZEBOV-GP, live attenuation) has received accelerated review status in the U.S. and EU.
- The FDA has tagged V920 a Breakthrough Therapy which provides for more intensive guidance from the FDA review team, the involvement of more senior agency personnel and a rolling review of the New Drug Application (NDA).
- The European Medicines Agency (EMA) has granted PRIME status to V920 which provides early and proactive support from the regulator, including the appointment of a liaison called a rapporteur, with the aim of optimizing clinical trial design as well as accelerated review of the Marketing Authorization Application (MAA).
- Merck licensed V920 from NewLink Genetics (NLNK +1.6%) in late 2014.