WASHINGTON - The COVID-19 antibody drugs from Regeneron and Eli Lilly should no longer be used because they do not work against the Omron version that is now available in almost all U.S. states. Responsible for infections, U.S. health regulators said Monday night.
The decision removed a key component from Florida Gov. Ron DeSantis' strategy of fighting the virus through treatment rather than emphasizing preventive measures such as vaccination and wearing masks.
DeSantis's office sent a statement blasting the federal government for the "sudden and reckless decision," claiming it was done "without a single piece of clinical data." The Florida Department of Health announced that all of its antibody clinics were closing.
The Food and Drug Administration said it was revoking emergency authorization for both drugs, which were purchased by the federal government and administered to millions of Americans with COVID-19. If the drugs prove effective against future variants, the FDA said it could reauthorize their use.
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Despite DeSantis' allegations, the regulatory move was expected as both drugmakers said its mutations made infusion drugs less able to target Omicron.
Omicron's resistance to two major monoclonal antibody drugs has improved the treatment book for COVID-19 in recent weeks.
Doctors have alternative treatments to fight 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 seems to be effective is also in short supply.
The drugs are laboratory-produced versions of virus-blocking antibodies. These aim to avoid serious illness and death by supplying a concentrated dose of one or two antibodies early in the infection. Then-President Donald Trump received Regeneron's antibody combination in 2020 after testing positive for the coronavirus.
The FDA noted in its decision that Omicron is more than 99% of the U.S. infections, making it "highly unlikely" that antibodies will now help people seek treatment. The agency said restricting their use would also eliminate unnecessary drug side effects, including allergies.
The US government temporarily stopped distributing the two drugs in late December, as Omicron raced to become the dominant version nationwide. But officials resumed distribution after complaints from Republican governors, including DeSantis, who claimed 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 vaccination sites and applauding them at news conferences, 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 those who are most vulnerable, including seniors, transplant recipients and people with conditions such as heart disease and diabetes.
Since early January, the US government has shipped enough doses of the two antibodies to treat more than 300,000 patients.
Both Regeneron and Lilly previously announced that they were developing new antibodies that target Omicron.
The move comes days after regulators widened the use of remdesivir - the first drug approved for COVID-19 - to treat more patients.
On Friday, the FDA expanded approval of antivirals to include adults and children with early COVID-19 who face a high risk of ending up in hospital. Remdesivir was previously limited to hospitalized patients.
An influential panel of federal experts had already recommended using the infused drug to try to prevent hospitalizations. The same guidelines from the National Institutes of Health panel recommend against continued use of the antibody drugs Lilly and Regeneron because of their low effectiveness against Omicron.
Still, many hospitals will face challenges in expediting remdesivir treatment. The drug requires three consecutive IV infusions over three days when used for non-hospitalized patients. This time-consuming process will not be an option for many high capacity hospitals facing staff shortage.
The FDA made its decision based on a study of 560 patients that showed a nearly 90% reduction in hospitalizations when remdesivir was given within seven days of symptoms. The study predates the Omron version, but like other antivirals, remdesivir is expected to maintain its performance against the latest version.