Abstract
Casirivimab/imdevimab (Ronapreve™; REGEN-COV™) is a co-packaged combination of two neutralizing immunoglobulin gamma 1 (IgG1) human monoclonal antibodies (casirivimab and imdevimab) against the spike protein of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of coronavirus disease 2019 (COVID-19). Casirivimab/imdevimab received its first emergency use authorization for the treatment of COVID-19 in November 2020 in the USA, with similar authorizations subsequently granted in various other countries, including India, Canada, and Switzerland. In February 2021, casirivimab/imdevimab was granted a positive scientific opinion in the EU for the treatment of COVID-19. In July 2021, casirivimab/imdevimab received its first approval in Japan for the treatment of mild or moderate COVID-19, followed in August 2021 by its conditional approval for the prophylaxis and treatment of acute COVID-19 infection in the UK. The combination was also granted provisional determination in Australia in August 2021, indicating its eligibility to be considered for provisional registration for COVID-19 treatment and prevention. This article summarizes the milestones in the development of casirivimab/imdevimab leading to these first approvals for COVID-19.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40265-021-01620-z.
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
