U.S FDA curbs use of two antibody drugs sidelined by omicron

FDA curbs use of antibody drugs sidelined by omicron WASHINGTON (AP) — COVID-19 antibody drugs from Regeneron and Eli Lilly should no longer be used because they are unlikely to work against the omicron variant that now accounts for nearly all U.S. infections, U.S. AP NEWS

... The Food and Drug Administration said it was revoking emergency authorization for both drugs, which were purchased by the federal government and given 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. ...

he U.S. government temporarily stopped distributing the two drugs in late December, as omicron was racing across the country to become the dominant variant. But officials resumed distribution after complaints from Republican governors, including Florida’s Ron DeSantis, who claimed that the drugs continued to help some omicron patients.

DeSantis has heavily promoted antibody drugs as a signature part of his administration’s COVID-19 response, setting up infusion sites and lauding them at news conferences, while opposing vaccine mandates and other public health measures. Texas Gov. Greg Abbott has also launched state-sponsored infusion sites.

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.

Since early January, the U.S. government has shipped enough doses of the two antibodies to treat more than 300,000 patients.

Both Regeneron and Lilly previously announced they were developing new antibodies that target omicron.

The move comes days after regulators broadened the use of remdesivir — the first drug approved for COVID-19 — to treat more patients. ...