The FDA revoked emergency authorization for COVID-19 monoclonal antibody drugs from Regeneron and Eli Lilly for being ineffective against omicron.
WASHINGTON -- COVID-19 antibody drugs from Regeneron and Eli Lilly should no longer be used because they don't work against the omicron variant that now accounts for nearly all U.S. infections, U.S. health regulators said Monday.
Omicron's resistance to the two leading monoclonal antibody medicines has upended the treatment playbook for COVID-19 in recent weeks. The FDA noted in its decision that omicron accounts for more than 99% of U.S. infections, making it"highly unlikely" the antibodies would help people now seeking treatment. The agency said restricting their use would also eliminate unnecessary drug side effects, including allergic reactions.
The drugs are not a substitute for vaccination and are generally reserved for people who are the most vulnerable, including seniors, transplant recipients and those with conditions like heart disease and diabetes. The move comes days after regulators broadened the use of remdesivir - the first drug approved for COVID-19 - to treat more patients.
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