Ridgeback Biotherapeutics LP ("Ridgeback"), a biotechnology company experienced in antiviral drug development, today announced the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) and granted priority review designation for Ridgeback’s investigational Ebola treatment, ansuvimab (mAb114). The FDA granted Breakthrough Therapy Designation status to ansuvimab as a treatment for Ebola in September 2019.
Wendy Holman, CEO and co-founder of Ridgeback, said: "We are at a critical point in time for global health. The world is experiencing what it is like when a virus dominates everyday life. Ansuvimab is a vital tool in the global health armamentarium that will help to keep Ebola in check and stop local epidemics from becoming global pandemics. This powerful experimental treatment has demonstrated an impressive survival benefit in Ebola patients and will supply much needed help to the patients and communities who battle Ebola.
"Protecting communities and patients from this aggressive and merciless virus is a driving force at Ridgeback. I am extraordinarily proud of the incredible work of the Ridgeback team, and grateful for the tireless support of our partners around the globe. We are very appreciative for the dedicated team at the FDA who has given great attention and thought toward this application and the patients who may benefit from it.
"Ridgeback continues to manufacture ansuvimab and is looking forward to working with nonprofit organizations and African nations to ensure that ansuvimab will be made available to patients who need it. Ridgeback will be completing a large drug product campaign for ansuvimab in the third quarter of 2020. This medicine will also be donated to African nations and non-governmental organizations that will work with Ridgeback to implement a compassionate use protocol for patients."
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 (DRC). 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.
About Ridgeback Biotherapeutics LP:
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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