The FDA's Breakthrough Therapy Designation is intended to expedite the development and review of a candidate that is planned for use, alone or in combination, to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.
PRIME is an approach from the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need. PRIME is intended to optimize development plans and speed up assessment of the medicine's application so these medicines may potentially reach patients earlier. PRIME focuses on medicines that may offer a major therapeutic advantage over existing treatments, or benefit patients without treatment options. These medicines are considered priority medicines by EMA. To be accepted for PRIME, a medicine has to show its potential to benefit patients with unmet medical needs based on early clinical data.
"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," said Paula Annunziato, M.D., vice president for clinical research, Merck Research Laboratories.
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, when the peak of the Ebola outbreak in western Africa was at its worst, Merck licensed V920 from NewLink Genetics, with the goal of accelerating the development, licensure, and availability of this candidate vaccine. Since that time, Merck has worked closely with NewLink Genetics and a number of external collaborators to enable a broad clinical development program with funding from the U.S. Government including the Department of Health and Human Service’s Biomedical Advanced Research Development Authority (BARDA) and the Department of Defense's Defense Threat Reduction Program/Joint Vaccination Acquisition Program (DTRA/JVAP) among others. Additional research evaluating V920 is ongoing.
Merck is responsible for the research, development, manufacturing, and regulatory efforts in support of V920. The company has committed to working closely with other stakeholders to accelerate the continued development, production and, if licensed, distribution of the vaccine.
Merck's Commitment to infectious diseases
For more than 80 years, Merck has contributed to the discovery and development of novel medicines and vaccines to combat infectious disease. In addition to a combined portfolio of antibiotic and antifungal medicines, vaccines, and medicines for HIV and HCV. Merck has multiple programs that span discovery through late-state development. Merck currently has 10 compounds in Phase 2/Phase 3 clinical trials for the potential treatment or prevention of infectious diseases.
For 125 years, Merck has been a global health care leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships.