FDA Greenlights Regeneron's Antibody Cocktail for Ebola



The U.S. Food and Drug Administration (FDA) has approved the antibody cocktail Inmazeb for the treatment of the Ebola Virus in adult and pediatric patients. The announcement, which was made on October 14th, comes more than two years since the second-largest Ebola outbreak in the Democratic Republic of Congo.


Manufactured by Regeneron, Inmazeb is a mixture of three monoclonal antibodies (atoltivimab, maftivimab, and odesivimab-ebgn), which all work to block the virus’ glycoprotein from attaching and infecting a healthy cell. Glycoprotein attaches to the cell receptor and fuses the viral and host cell membranes, allowing it to enter the cell. The three antibodies in Inmazeb can bind to this glycoprotein simultaneously and block the virus's attachment and entry.


In a clinical trial called the PALM trial conducted during the outbreak in the North Kivu region of DRC in 2018 and 2019 in 382 adults, those treated with Inmazeb (formerly known as REGN-EB3) experienced 33.55% mortality after 28 days. The trial was led by the U.S. National Institutes of Health and the DRC’s Institut National de Recherché Biomedicale. Prior to the commencement of the clinical trial, the World Health Organization (WHO) had fears about the downsides of carrying out a trial during an emergency because it could take resources meant for treating patients.


“Today’s action demonstrates the FDA’s ongoing commitment to responding to public health threats – both domestically and abroad – on the basis of science and data,” said FDA Commissioner Stephen M. Hahn, M.D. “This approval was made possible because of our steadfast dedication to facilitating the development of safe and effective treatments for infectious diseases as part of our vital public health mission."


Inmazeb received an Orphan Drug designation for the treatment of Ebola virus infection. The Orphan Drug designation gives incentives to help and encourage drug development for rare diseases. In addition, the agency granted Inmazeb a Breakthrough Therapy designation for the treatment of Zaire Ebola virus infection. The FDA aims to approve Regeneron Pharmaceuticals.




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