Merck Gets Breakthrough Therapy Status From FDA And PRIME Status From EMA For Investigational Ebola Zaire Vaccine

Merck & Co., Inc. MRK revealed Monday about two regulatory milestones for its investigational vaccine for Ebola Zaire, V920 (rVSV∆G-ZEBOV-GP, live attenuated). While the Food and Drug Administration has granted the vaccine candidate Breakthrough Therapy Status, the European Medicines Agency (EMA) has accorded PRIME (PRIority MEdicines) status.

Merck said the FDA's Breakthrough Therapy Designation was planned to expedite the development, as well as review of a candidate that was planned for use, alone or in combination, to treat a serious or life-threatening disease. The company indicated that the candidate could be used when preliminary clinical evidence indicated that the drug might demonstrate substantial enhancement from existing therapies on one or more clinically significant endpoints.

The drug maker said that PRIME is an approach from the European Medicines Agency (EMA) to improve support for the development of medicines, which focuses on an unmet medical requirement. The company added that PRIME was planned to maximize development plans and speed up assessment of the medicine's application so these medicines might possibly reach patients earlier. The company added that to be accepted for PRIME, a drug has to demonstrate its potential to benefit patients with unmet medical requirements based on early clinical data.

Merck's VP for clinical research, Paula Annuziato, said, "The granting of Breakthrough Therapy Designation by the FDA and PRIME status by the EMA will enable us to continue to accelerate development of V920, and we greatly appreciate the collaboration of these agencies in moving this vaccine candidate forward in potentially meeting this public health need."

The company indicated 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, Merck licensed V920 from NewLink Genetics, with the goal of accelerating the development, licensure, and availability of this candidate vaccine.