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.
