Ansuvimab: First Approval

Declarations

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

Authorship and Conflict of interest During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. A. Lee is a salaried 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.

Abstract

Ansuvimab (ansuvimab-zykl; EBANGA™) is a human monoclonal antibody developed by Ridgeback Biotherapeutics, which binds to the glycoprotein on Zaire ebolavirus (Ebola virus) to block its entry into host cells. Ansuvimab has been recently approved in the USA for the treatment of infection caused by Z. ebolavirus in adult and paediatric patients, including in neonates born to a mother who is RT-PCR positive for Z. ebolavirus infection, following the results of the PALM phase II/III trial. This article summarizes the milestones in the development of ansuvimab leading to this first approval for the treatment of infections caused by Ebola virus in adults and paediatric patients.