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Review

REGN-EB3 – Atoltivimab, Maftivimab, Odesivimab: Short Chapter

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In: LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012.
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Review

REGN-EB3 – Atoltivimab, Maftivimab, Odesivimab: Short Chapter

No authors listed.
Free Books & Documents

Excerpt

Atoltivimab, maftivimab, and odesivimab are three human monoclonal antibodies to Zaire ebolavirus that are given in combination and used to treat children and adults with acute Zaire ebolavirus infection. Therapy with atoltivimab, maftivimab, and odesivimab has not been associated with serum aminotransferase elevations nor to instances of clinically apparent liver injury.

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References

    1. FDA. Integrated Review. 2020. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761169Orig1s000M...(FDA summary data on the safety and efficacy of the combination of atoltivimab, maftivimab, and odesivimab [REGN-EB3], submitted in support of the application for approval as therapy of Zaire ebolavirus infection, mentions that ALT elevations arose in 31.8% of 154 patients receiving REGN-EB3 vs 31.0% of 168 receiving a control monoclonal antibody, while ALT values above 5 times ULN arose in 10.4% vs 14.3%).
    1. Sivapalasingam S, Kamal M, Slim R, Hosain R, Shao W, Stoltz R, Yen J, et al. Safety, pharmacokinetics, and immunogenicity of a co-formulated cocktail of three human monoclonal antibodies targeting Ebola virus glycoprotein in healthy adults: a randomised, first-in-human phase 1 study. Lancet Infect Dis. 2018;18:884-893. - PubMed
    1. Mulangu S, Dodd LE, Davey RT Jr, Tshiani Mbaya O, Proschan M, Mukadi D, Lusakibanza Manzo M, et al.; PALM Consortium Study Team. A randomized, controlled trial of Ebola virus disease therapeutics. N Engl J Med. 2019;381:2293-2303. - PMC - PubMed
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