REGN-EB3: First Approval

REGN-EB3 (INMAZEB(R), 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.

Automated summary

REGN-EB3, a combination of three fully-human monoclonal antibodies targeting Ebola virus glycoprotein, was recently approved by the US FDA based on the PALM study conducted during an Ebola outbreak in the Democratic Republic of Congo. This marks a significant milestone in the development of REGN-EB3 as a treatment for Zaire ebolavirus infection in adult and paediatric patients.