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# FDA Limits Lilly, Regeneron Covid Therapies
- URL: https://www.fdaweb.com/fda-limits-lilly-regeneron-covid-therapies/
- Published: 2022-01-24T12:00:00.000Z
- Updated: 2026-09-14T17:29:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150991

Due to effectiveness concerns in treating the Covid-19 omicron variant, FDA has revised Eli Lilly’s [emergency use authorization](http://email.prnewswire.com/ls/click?upn=3slWLw94I3jq-2B-2FedjFNgZAmdierth9sDznGHUIlSHO9lzq0tGktuJ7wJ0dAAotAT1T3Jcnd6FGluDdKDbM9dtQ-3D-3DdORK%5FxCGFIN3nMOPWun4BAdUrZI6NUVIWPuhGNPih1t9UspWUawZ-2BSsLNM-2FdqNsHgZvBOEKwAYT0ZV6ACSUaakHFqiGQRQghjPbvf6CAm-2BEhZX7Dzjqv5xHqktBtRs4MP6gl43Y6j5IBcRudV9HnyiZg-2FJg2Rgo43ctU19J2jpGDyw-2BNlmD7dWAvWjnVhpRLwRGQn9W-2FjA-2FFNnzVFZUo1WaMSgUut02BDBh0M8jBVMzGR6pLwLQqY9JJgNM7i7k6h3KbwfiGyTfmt2LPeO1L4061P-2BM-2BYtBiNJ5yekwY6m1jmmFIYwxN-2BqqXecHwoGW0IqeF6ctdBxg4Yjr9HzGtWU9SxAfSIQnG8ZOkZSVuVX37w7CUDS9pV86-2B3BytS6btQucSZ&ref=fdaweb.com) for bamlanivimab and etesevimab and Regeneron’s [emergency use authorization for Regen-Cov (casirivimab and imdevimab](https://www.fda.gov/media/145610/download?ref=fdaweb.com)). Both authorizations have now been limited for use only when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments, the agency says in a [1/24 notice](https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-limits-use-certain-monoclonal-antibodies-treat-covid-19-due-omicron?ref=fdaweb.com).  

“Because data show these treatments are highly unlikely to be active against the omicron variant, which is circulating at a very high frequency throughout the United States, these treatments are not authorized for use in any U.S. states, territories, and jurisdictions at this time,” FDA explains. “In the future, if patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to these treatments, then use of these treatments may be authorized in these regions.”

FDA’s notice says there are “[several other therapies](http://email.prnewswire.com/ls/click?upn=3slWLw94I3jq-2B-2FedjFNgZEsgIlGJ16zoxxQ23Z-2Fxh9Z75ZdNjPUxA9lcC1RonAJ8RR3B6hxnb4uOEbdAvOTQOWZdl2TFlA9rTHZcFkxaFtoJpWWC8USB4Z0Lkw2Eoyp32foYSjXLNKsHdtV2z79g6QId7SYe1p6qmPGu-2FjNakWEI9c9n0H-2Biew0fgGdTRaNBWLVu%5FxCGFIN3nMOPWun4BAdUrZI6NUVIWPuhGNPih1t9UspWUawZ-2BSsLNM-2FdqNsHgZvBOP9Ci4lgb6agnvMiSQqTRvc-2F46eNxBPGYQqCsTm1uA8CFD0caeLEWBaYKyGI6eO2AJNJShWOwyaleWfuTAoqmLaFisr79M-2F5i4I0GarZsECXZzGdd-2FLPeqEDAs1g6Z-2BggV-2Fk-2FPjKpCYFqoMbFRMKwLV0b-2Fh51-2FSfUgKOZ3xz0NNdWlljhrZbMXLyYMXfLpjMSH0ngXVcqRsmG-2FkGXts2IvR907iTP0w4jQ-2BmhhOaNDFY-2BowK8B-2FnJd5Ffk8qnkllj0ZiB9HsvFeBCYdz41ePKUdFmFEVnF-2FxryfQsqnL2j4SeM7Rl8MI5O5H3IHaBwPu5&ref=fdaweb.com) – Paxlovid, sotrovimab, Veklury (remdesivir), and molnupiravir – that are expected to work against the omicron variant, and that are authorized or approved to treat patients with mild-to-moderate Covid-19 who are at high risk for progression to severe disease, including hospitalization or death.