Regeneron Fail
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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.
The Food and Drug Administration said it was revoking emergency authorization for both drugs, which were purchased by the federal government and have been administered to millions of Americans with COVID-19. If the drugs prove effective against future variants, the FDA said it could reauthorize their use.
The regulatory move was expected because both drugmakers had said the infusion drugs are less able to target omicron due to its mutations. Still, the federal action could trigger pushback from some Republican governors who have continued promoting the drugs against the advice of health experts.
Omicron’s resistance to the two leading monoclonal antibody medicines has upended the treatment playbook for COVID-19 in recent weeks.
Doctors have alternate therapies to battle early COVID-19 cases, including two new antiviral pills from Pfizer and Merck, but both are in short supply. An antibody drug from GlaxoSmithKline that remains effective also is in short supply.
The drugs are laboratory-made versions of virus-blocking antibodies. They are intended to head off severe disease and death by supplying concentrated doses of one or two antibodies early in an infection. Then-President Donald Trump received Regeneron’s antibody combination after he tested positive for the coronavirus in 2020.