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Merck's Ebola vaccine granted breakthrough therapy status
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Merck announced today that its investigational Ebola vaccine, V920, was granted breakthrough therapy designation by the FDA
The vaccine also was granted priority medicines (PRIME) status by the European Medicines Agency.
“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,” Paula Annuziato, MD, vice president for clinical research at Merck Research Laboratories, said in a news release.
background: white none repeat scroll 0% 0%;">V920 targets the Zaire ebolavirus species, which was responsible for the 2014 Ebola outbreak in West Africa. The live-attenuated vaccine was initially engineered by scientists at the Public Health Agency of Canada’s National Microbiology Laboratory. It was subsequently licensed to a subsidiary of NewLink Genetics, which then licensed it to Merck during the peak of the 2014 outbreak to speed its development and approval.
According to the FDA, a breakthrough therapy is drug that is “intended alone or in combination with one or more other drugs to treat a serious or life-threatening disease or condition” and one in which “preliminary clinical evidence [has indicated] that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.” Under the designation, the FDA will expedite the development and review of V920.
Similarly, the EMA’s PRIME designation is intended to give enhanced support to medicines that target an unmet need, speeding their development and evaluation.
Disclosure: Annuziato is an employee of Merck.