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REGN-EB3: First Approval

online resource

posted on 2021-01-11, 20:27 authored by Anthony Markham

Declarations

Funding The preparation of this review was not supported by any external funding.

Authorship and Conflict of interest Anthony Markham is a contracted employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.

Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability not applicable

Additional information about this Adis Drug Review can be found here

Abstract REGN-EB3 (INMAZEB^®, Regeneron Pharmaceuticals) is a combination of three fully-human monoclonal antibodies – atoltivimab (REGN3470), maftivimab (REGN3479), and odesivimab (REGN3471) – that target Ebola virus glycoprotein. Based on the results of the PALM study conducted during an Ebola outbreak in the Democratic Republic of Congo, REGN-EB3 was recently approved by the US FDA as a treatment for Ebola virus infection. This article summarizes the milestones in the development of REGN-EB3 leading to this first approval for the treatment of infection caused by Zaire ebolavirus (Ebola virus) in adult and paediatric patients.