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Casirivimab/Imdevimab: First Approval
1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.
Drugs
|October 30, 2021
Summary
Casirivimab/imdevimab, a combination of two neutralizing monoclonal antibodies, received emergency use authorization and approvals for treating and preventing COVID-19 globally. This summary highlights key development milestones for the COVID-19 therapy.
Area of Science:
- Immunology
- Virology
- Pharmacology
Background:
- Casirivimab/imdevimab is a combination therapy comprising two neutralizing human monoclonal antibodies targeting the SARS-CoV-2 spike protein.
- It is developed for the treatment and prevention of COVID-19, caused by the SARS-CoV-2 virus.
Purpose of the Study:
- To summarize the development milestones of casirivimab/imdevimab.
- To document the timeline of regulatory approvals and authorizations for COVID-19 treatment and prophylaxis.
Main Methods:
- Review of regulatory submissions and approvals.
- Chronological summary of key development events.
Main Results:
- Casirivimab/imdevimab received its first emergency use authorization in the USA in November 2020.
- Subsequent authorizations and approvals were granted in various countries including India, Canada, Switzerland, EU, Japan, UK, and Australia.
- The therapy gained approvals for both treatment and prophylaxis of COVID-19.
Conclusions:
- Casirivimab/imdevimab has achieved significant global regulatory milestones for COVID-19 treatment and prevention.
- The development timeline reflects the rapid progression of this therapeutic antibody combination.
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