Policy & Regulation
US FDA Grants Priority Review of Biologics License Application for Ansuvimab Ebola Treatment
31 July 2020 - - The US Food and Drug Administration has accepted the Biologics License Application and granted priority review designation for US-based biotechnology company Ridgeback Biotherapeutics LP's investigational Ebola treatment, ansuvimab (mAb114), the company said.

The FDA granted Breakthrough Therapy Designation status to ansuvimab as a treatment for Ebola in September 2019.

Ansuvimab is a monoclonal antibody isolated from a human survivor of the 1995 Ebola outbreak in Kikwit, a city in the Democratic Republic of the Congo. Nancy Sullivan, Ph.D., Chief of the Biodefense Research Section at the National Institute of Allergy and Infectious Diseases, Vaccine Research Center, and her team discovered that the survivor retained antibodies against Ebola 11 years after infection.

The team isolated the antibodies, tested the most favorable ones in both laboratory and nonhuman primate studies, and selected ansuvimab as the most promising.

Jean-Jacques Muyembe-Tamfum, M.D., Ph.D., director-General of DRC's National Institute for Biomedical Research and one of the scientists involved in the original detection of the Ebola virus in 1976, played a key role in discovering ansuvimab.

Ansuvimab development has been funded in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract Numbers 75A50119C00059 and 75A50120C0009.

Headquartered in Miami, Florida, Ridgeback Biotherapeutics, LP is a biotechnology company focused on emerging infectious diseases.

Ridgeback has two late-stage treatments in development ansuvimab for the treatment of Ebola virus disease and EIDD-2801/MK 4482 for treatment of COVID-19.

Initial funding for Ridgeback Biotherapeutics, LP originated from Wayne and Wendy Holman, who are committed to investing in and supporting medical technologies that will save lives.

The team at Ridgeback is dedicated to working toward finding life-saving and life-changing solutions for patients and diseases that need champions.
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