2025-14233Notice

FDA Shuts Down Emergency Use for Major COVID Antibody Drugs

Published Date: 7/29/2025

Notice

Summary

The FDA has officially ended the emergency use of several COVID-19 antibody treatments from Regeneron, GSK, Lilly, and AstraZeneca as of December 13, 2024. This means these drugs can no longer be used under emergency rules, affecting patients and healthcare providers relying on them. The change reflects updated safety and effectiveness info, so folks should look for other treatment options moving forward.

Analyzed Economic Effects

2 provisions identified: 0 benefits, 2 costs, 0 mixed.

EUA Revoked for Four COVID Antibodies

On December 13, 2024, the FDA revoked the Emergency Use Authorizations for REGEN-COV (casirivimab and imdevimab), sotrovimab, bebtelovimab, and EVUSHELD (tixagevimab co-packaged with cilgavimab). This means these drugs can no longer be used under emergency rules and may affect patients and health care providers who relied on them.

Revocations Cited Safety/Effectiveness; Find Alternatives

The FDA said the revocations reflect updated safety and effectiveness information and advises people who used or would have used these treatments to look for other treatment options going forward. The revocations took effect December 13, 2024.

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Key Dates

Effective Date
Published Date
12/13/2024
7/29/2025

Department and Agencies

Department
Independent Agency
Agency
Health and Human Services Department
Food and Drug Administration
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