REGN-EB3: First Approval

<p><b>Declarations</b></p><p><b>Funding </b>The preparation of this review was not supported by any external funding.</p> <p> </p> <p><b>Authorship and Conflict of interest</b> 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.</p> <p> </p> <p><b>Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability</b> not applicable</p> <p> </p> <p>Additional information about this Adis Drug Review can be found <a href="http://www.springer.com/gp/adis/products-services/adis-journals-newsletters/adis-drug-reviews">here</a><b></b></p> <p> </p> <p><b>Abstract </b>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 <i>Zaire ebolavirus</i> (Ebola virus) in adult and paediatric patients.</p><p><br></p><p>© Springer Nature Switzerland AG 2021<br></p><br><p></p>