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Drug Review Profile Approvals Review Pathway

US FDA's Ebola Drug Approvals Showcase Efficiencies With Master Protocols

  • Analysis

Executive Summary

Agency approved Regeneron’s monoclonal antibody cocktail Inmazeb and Ridgeback’s mAB Ebanga on data from a multi-arm, adaptive trial in which several investigational agents were independently compared to a control group. Efficacy for both drugs was demonstrated on a mortality endpoint, with lingering uncertainties to be addressed through postmarketing studies.

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Inmazeb Clinical Development Timeline

Chronicle of the development and review of Regeneron’s REGN-EB3, a triple mAB combination treatment for Ebola infection.

Inmazeb Clinical Development Timeline

Chronicle of the development and review of Regeneron’s REGN-EB3, a triple mAB combination treatment for Ebola infection.

Ebanga Clinical Development Timeline

Chronicle of the development and review of Ridgeback Biotherapeutics’ ansuvimab-zykl for treatment of Ebola infection.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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