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Casirivimab/Imdevimab: First Approval.

¹Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.

|October 30, 2021

Summary

This summary is machine-generated.

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.

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Paramyxoviruses for Tumor-targeted Immunomodulation: Design and Evaluation Ex Vivo

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Published on: January 7, 2019

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.