Atoltivimab, maftivimab, and odesivimab (Inmazeb) - To treat ebola virus Drug Approval Package: INMAZEB * Skip to main page content * Skip to search * Skip to topics menu * Skip to common linksHHS U.S. Department of Health and Human Services U.S. Food and Drug Administration * Follow FDA * En EspañolSearch FDASubmit search * Popular Content * Home * Food * Drugs * Medical Devices * Radiation
Committee recommended the addition of the monoclonal antibodies ansuvimab and atoltivimab + maftivimab + odesivimab to the core list of the EML and EMLc for the treatment of confirmed Ebola virus disease caused by Zaire ebolavirus in adults and children, and in neonates of unconfirmed infection status aged 7 days or younger, born to mothers with confirmed infection. The Committee noted that Ebola virus disease is a life-threatening disease with a high case-fatality rate, for which effective treatments are of public health importance. The Committee considered that the available clinical trial evidence for ansuvimab and atoltivimab + maftivimab + odesivimab has demonstrated important reductions in mortality compared to standard supportive care alone. The Committee considered that their inclusion
; 2135632-30-1Go to:Drug Levels and EffectsSummary of Use during LactationInmazeb is a mixture of monoclonal antibodies, atoltivimab, maftivimab, and odesivimab that are directed against Zaire ebolavirus glycoprotein. No information is available on the use of Inmazeb during breastfeeding. Because Inmazeb is a mixture of large protein molecules with molecular weights of 144,000 to 146,000 Da, the amount ProcessFact Sheet. Drugs and Lactation Database (LactMed)Drugs and Lactation Database (LactMed) - GlossaryLactMed Selected ReferencesDrugs and Lactation Database (LactMed) - About Dietary SupplementsBreastfeeding LinksSimilar articles in PubMedAtoltivimab/maftivimab/odesivimab (Inmazeb) combination to treat infection caused by Zaire ebolavirus.[Drugs Today (Barc). 2021]Review REGN-EB3: First Approval.[Drugs
. Inmazeb (REGN-EB3), developed by Regeneron, is a cocktail of 3 neutralizing humanized mAbs directed against 3 EBOV GP epitopes (atoltiviMab, maftiviMab and odesiviMab). It is indicated for the treatment of EVD in adult patients (including pregnant women) and in children, including neonates whose mothers have EVD at the time of delivery. Inmazeb inhibits viral entry into the target cell (12
demonstrated efficacy in the treatment of Ebola hemorrhagic fever. * * Ebola Zaire vaccine is approved in Europe and the United States. The live recombinant vaccine has shown effectiveness of 97.5% in preventing infection among 90,000 individuals in an active Ebola virus outbreak in the Democratic Republic of Congo. [2] * * The FDA approved atoltivimab/maftivimab/odesivimab (Inmazeb), a recombinant
demonstrated efficacy in the treatment of Ebola hemorrhagic fever. * * Ebola Zaire vaccine is approved in Europe and the United States. The live recombinant vaccine has shown effectiveness of 97.5% in preventing infection among 90,000 individuals in an active Ebola virus outbreak in the Democratic Republic of Congo. [2] * * The FDA approved atoltivimab/maftivimab/odesivimab (Inmazeb), a recombinant
and should include replacement of coagulation factors and heparin if disseminated intravascular coagulation develops. Such care must be administered with strict attention to barrier isolation. All body fluids (blood, saliva, urine, and stool) contain infectious virions and should be handled with great care.The recombinant monoclonal antibody combination, atoltivimab/maftivimab/odesivimab (Inmazeb infection in humans.The recombinant monoclonal antibody combination,atoltivimab/maftivimab/odesivimab(Inmazeb; REGN-EB3), is the first reatment for Zaire ebolavirus and was approved by the US Food and Drug Administration (FDA) in October 2020. It is indicated for treatment of Zaire ebolavirus in adults and children, including neonates born to a mother who is reverse-transcriptase polymerase chain reaction
and should include replacement of coagulation factors and heparin if disseminated intravascular coagulation develops. Such care must be administered with strict attention to barrier isolation. All body fluids (blood, saliva, urine, and stool) contain infectious virions and should be handled with great care.The recombinant monoclonal antibody combination, atoltivimab/maftivimab/odesivimab (Inmazeb infection in humans.The recombinant monoclonal antibody combination,atoltivimab/maftivimab/odesivimab(Inmazeb; REGN-EB3), is the first reatment for Zaire ebolavirus and was approved by the US Food and Drug Administration (FDA) in October 2020. It is indicated for treatment of Zaire ebolavirus in adults and children, including neonates born to a mother who is reverse-transcriptase polymerase chain reaction
] Medication Atoltivimab/maftivimab/odesivimab (Inmazeb) Prognosis 25–90% mortality[1 in the United States in December 2019.[9] While there is no approved treatment for Ebola as of 2019[update],[10] two treatments (atoltivimab/maftivimab/odesivimab and ansuvimab) are associated with improved outcomes.[11] Supportive efforts also improve outcomes.[1] These include oral rehydration therapy (drinking slightly sweetened and salty water) or giving intravenous fluids, and treating symptoms.[1
Resources Interventions Go to Top of Page Study Description Study Design Interventions Eligibility Criteria Contacts and Locations More Information Intervention Details: * Biological: REGN3470-3471-3479Other Names: * REGN-EB3 * Inmazeb® * atoltivimab, maftivimab, and odesivimab Eligibility CriteriaGo to Top of Page Study Description Study Design Interventions Eligibility Criteria Contacts Last Verified: April 2022 Keywords provided by Regeneron Pharmaceuticals: Positive Ebola Virus (EBOV) diagnostic test symptomatic Additional relevant MeSH terms: Virus Diseases Atoltivimab, maftivimab, and odesivimab-ebgn drug combination Hemorrhagic Fever, Ebola Atoltivimab