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Casirivimab/Imdevimab: First Approval

Drugs (New York, N.Y.), 2021-11, Vol.81 (17), p.2047-2055 [Peer Reviewed Journal]

The Author(s), under exclusive licence to Springer Nature Switzerland AG 2021 ;2021. The Author(s), under exclusive licence to Springer Nature Switzerland AG. ;Copyright Springer Nature B.V. Nov 2021 ;ISSN: 0012-6667 ;EISSN: 1179-1950 ;DOI: 10.1007/s40265-021-01620-z ;PMID: 34716907

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Title:
Casirivimab/Imdevimab: First Approval
Author: Deeks, Emma D.
Subjects: AdisInsight Report ; Agreements ; Antibodies, Monoclonal, Humanized - adverse effects ; Antibodies, Monoclonal, Humanized - pharmacokinetics ; Antibodies, Monoclonal, Humanized - pharmacology ; Antibodies, Monoclonal, Humanized - therapeutic use ; Coronaviruses ; COVID-19 ; COVID-19 - drug therapy ; Disease prevention ; Drug Approval ; Drug Combinations ; Health services ; Humans ; Immunoglobulin G ; Internal Medicine ; Medicine ; Medicine & Public Health ; Monoclonal antibodies ; Pharmaceuticals ; Pharmacology/Toxicology ; Pharmacotherapy ; Prophylaxis ; SARS-CoV-2 ; Severe acute respiratory syndrome ; Severe acute respiratory syndrome coronavirus 2 ; Spike protein ; Viral diseases
Is Part Of: Drugs (New York, N.Y.), 2021-11, Vol.81 (17), p.2047-2055
Description: 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.
Publisher: Cham: Springer International Publishing
Language: English
Identifier: ISSN: 0012-6667
EISSN: 1179-1950
DOI: 10.1007/s40265-021-01620-z
PMID: 34716907
Source: MEDLINE
ProQuest Central

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Casirivimab/Imdevimab: First Approval

The Author(s), under exclusive licence to Springer Nature Switzerland AG 2021 ;2021. The Author(s), under exclusive licence to Springer Nature Switzerland AG. ;Copyright Springer Nature B.V. Nov 2021 ;ISSN: 0012-6667 ;EISSN: 1179-1950 ;DOI: 10.1007/s40265-021-01620-z ;PMID: 34716907

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