The US Food and Drug Administration (FDA) has granted V920 a breakthrough therapy designation which aims to expedite the development and review of a candidate that is planned for use, alone or in combination, to treat a severe or life-threatening disease or condition.
The status is also assigned to a medicine if preliminary clinical evidence suggests that the drug may show substantial enhancement over existing therapies on one or more clinically significant endpoints.
The European Medicines Agency (EMA) has granted PRIME status to V920 which intends to optimize development plans and accelerate assessment of the medicine’s application so these medicines may potentially reach patients earlier.
Merck said PRIME focuses on medicines that may provide a major therapeutic advantage over existing treatments, or benefit patients without treatment options.
Merck Research Laboratories vice president for clinical research Paula Annunziato 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.”
Germany-based Merck licensed V920 from NewLink Genetics in late 2014.
Merck is responsible for the research, development, manufacturing, and regulatory efforts in support of V920.
The company said it will work with other stakeholders to speed up the continued development, production and, if licensed, distribution of the vaccine.