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FDA Bans Use of Lilly, Regeneron COVID Drugs Due to Omicron

The FDA has restricted the use of COVID-19 antibody therapies from Eli Lilly and Regeneron, citing their ineffectiveness against the Omicron variant. This decision impacts the emergency use authorizations previously granted for these treatments, as nearly all new COVID-19 cases in the U.S. are now caused by Omicron.

The FDA has revised the emergency use authorizations (EUAs) for COVID-19 antibody therapies developed by Eli Lilly and Regeneron, stating they are "highly unlikely" to be effective against the Omicron variant. This variant is now responsible for almost all new COVID-19 cases in the United States.
Key Points:
  • FDA's Decision: The use of Lilly's bamlanivimab/etesevimab combination and Regeneron's REGEN-COV (casirivimab and imdevimab) is no longer authorized in any U.S. states, territories, or jurisdictions.
  • Reason for Restriction: Data suggests these treatments are not effective against the Omicron variant, which accounts for 99% of new COVID-19 cases.
  • Future Use: The FDA mentioned that these treatments might be authorized again in regions where patients are likely to be infected with a variant susceptible to these drugs.
  • Impact on Companies: This decision affects a significant revenue stream for both companies, with Lilly and Regeneron having recorded billions in sales from these treatments in 2021.
  • Alternative Treatments: The FDA and NIH recommend other treatments for COVID-19, including Pfizer's Paxlovid, GlaxoSmithKline/Vir Biotech's Xevudy, Gilead's Veklury, and Merck & Co/Ridgeback Bio's Lagevrio, which are expected to be effective against Omicron.
Conclusion: The FDA's decision underscores the challenges in treating COVID-19 as the virus evolves, highlighting the importance of adapting treatment strategies to the changing landscape of the pandemic.
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Reference News

[1]
FDA bans use of Lilly, Regeneron COVID drugs due to Omicron
pharmaphorum.com · Jan 3, 2025

FDA restricts Eli Lilly and Regeneron's COVID-19 antibody therapies due to inefficacy against Omicron, halting their use...

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