Inmazeb (REGN-EB3) Ebola Treatment Description
Inmazeb (REGN-EB3) is a novel anti-viral antibody cocktail that contains atoltivimab, maftivimab, and odesivimab-ebgn, developed using VelociSuite® proprietary rapid response technologies.
Regeneron's Inmazeb's three monoclonal antibodies of similar structure bind to different, non-overlapping epitopes on Zaire ebolavirus glycoprotein. The three antibodies help neutralize the Ebola virus disease (EVD) by blocking their ability to invade patients' and/or enlisting other immune cells to target infected cells and remove them from the body.
VelociGene enables rapid, automated, and high-scale manipulation of mouse DNA, with almost no limitations on the size and sophistication of modifications. This enables unprecedented speed and capacity to validate therapeutic targets and the creation of animal models of human disease. Under the NIH grant, we took on the challenge of targeting 3,500 of the most difficult genes.
Inmazeb (REGN-EB3) Ebola Treatment History
On October 14, 2020, Regeneron announced that the U.S. Food and Drug Administration approved Inmazeb to treat infection caused by Zaire ebolavirus in adult and pediatric patients, including newborns of mothers who have tested positive for the disease.
Regeneron expects to deliver an established number of treatment doses over the course of 6-years and receive compensation of approximately $10 million in 2021 and an average of $67 million per year for each of the next five years (2022-2026).
Inmazeb was developed in collaboration and with federal funds from BARDA, part of the Office of the Assistant Secretary for Preparedness and Response at the HHS under ongoing USG Contract Nos. HHSO100201700016C and HHSO100201500013C.
Regeneron Pharmaceuticals, Inc. is a leading biotechnology company that invents life-transforming medicines for people with serious diseases.
Inmazeb (REGN-EB3) Ebola Treatment Dosage
Inmazeb is administered as a single, weight-based intravenous infusion (50 mg atoltivimab, 50 mg maftivimab, and 50 mg odesivimab per kg).
Inmazeb (REGN-EB3) Ebola Treatment Limitations
The efficacy of INMAZEB has not been established for other species of the Ebolavirus and Marburgvirus genera. Zaire ebolavirus can change over time, and factors such as the emergence of resistance or changes in viral virulence could diminish the clinical benefit of antiviral drugs. Consider available information on drug susceptibility patterns for circulating Zaire ebolavirus strains when deciding to use INMAZEB.
INMAZEB may reduce the efficacy of a live vaccine; therefore, avoid the concurrent administration of a live vaccine during treatment with INMAZEB.
Inmazeb (REGN-EB3) Ebola Treatment News
December 12, 2020 - The NEJM published a study that found REGN-EB3 was superior to ZMapp in reducing mortality from EVD.
October 14, 2020 - The U.S. Food and Drug Administration approved Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn), a mixture of three monoclonal antibodies, as the first FDA-approved treatment for Zaire ebolavirus (Ebola virus) infection in adult and pediatric patients.
July 29, 2020 - Regeneron Pharmaceuticals announced that the Biomedical Advanced Research and Development Authority, part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, agreed to procure REGN-EB3 as part of the national preparedness for public health emergencies.
July 27, 2020 - Expanded Access Protocol for Treatment of Ebola Virus.
April 17, 2020 - The U.S. Food and Drug Administration accepted for Priority Review a new Biologics License Application (BLA) for REGN-EB3, an investigational triple antibody cocktail treatment for Ebola virus infection.
December 12, 2020 - NEJM published study: A Randomized, Controlled Trial of Ebola Virus Disease Therapeutics.
November 27, 2019 - Nearly 90 percent survival for patients who received REGN-EB3 treatment earlier in the course of their disease; 66.5 percent survival among all patients who received REGN-EB3.
November 26, 2018 - The Ministry of Health of the Democratic Republic of the Congo announced the launching of a randomized clinical trial to evaluate the effectiveness and safety of medications used in Ebola patients' treatment.
October 3, 2017 - The US government announced it is expanding the Strategic National Stockpile supply of vaccines and medications to better prepare for an Ebola outbreak.