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FDA stops use of antibody drugs that don’t work against omicron

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FDA stops use of antibody drugs that don’t work against omicron

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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.

The Food and Drug Administration said it was revoking emergency authorization for the two drugs, which were purchased by the federal government and have been given to millions of Americans with Covid-19. If the drugs prove effective against future variants, the FDA has said it may reauthorize their use.

This regulatory decision was expected because both drugmakers had said the infusion drugs were less able to target omicron due to its mutations. Still, the federal action could trigger a backlash from some Republican governors who have continued to promote the drugs against the advice of health experts.

Omicron’s resistance to the two leading monoclonal antibody drugs has upended the Covid-19 treatment playbook in recent weeks.

Doctors have alternative therapies to fight early cases of Covid-19, including two new antiviral pills from Pfizer and Merck, but both are in short supply. An antibody drug from GlaxoSmithKline that remains effective is also in short supply.

The FDA noted in its decision that omicron accounts for more than 99% of infections in the United States, making it “highly unlikely” that the antibodies will help people currently seeking treatment. The agency said restricting their use would also eliminate unnecessary drug side effects, including allergic reactions.

The US government temporarily stopped distributing both drugs in late December as omicron raced across the country to become the dominant variant. But authorities resumed distribution after complaints from Republican governors, including Florida’s Ron DeSantis, who said the drugs continued to help some omicron patients.

DeSantis has heavily promoted antibody drugs as an integral part of his administration’s Covid-19 response, setting up infusion sites and praising them at press conferences, while opposing mandates for vaccination and other public health measures. Texas Governor Greg Abbott has also launched state-sponsored infusion sites.

The drugs are not a substitute for vaccination and are generally reserved for the most vulnerable, including the elderly, transplant recipients, and people with 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.

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

The move comes days after regulators expanded the use of remdesivir – the first drug approved for Covid-19 – to treat more patients.

On Friday, the FDA expanded the antiviral’s approval to include adults and children with early Covid-19 who are at high risk of ending up in hospital. Remdesivir was previously limited to hospitalized patients.

An influential group of federal experts had previously recommended using the infused drug to try to avoid hospitalization. The same National Institutes of Health panel guidelines recommend against continued use of Lilly and Regeneron antibodies due to their reduced effectiveness against omicron.

Still, many hospitals will face challenges in accelerating remdesivir treatments. The drug requires three consecutive IV infusions over three days, when used for outpatients. This tedious process will not be an option for many overcapacity hospitals facing staff shortages.

The FDA made its decision based on a study of 560 patients that showed an almost 90% reduction in hospitalizations when remdesivir is given within seven days of symptoms. The study predates the omicron variant but, like other antivirals, remdesivir is expected to maintain performance against the latest variant.

FDA stops use of antibody drugs that don’t work against omicron

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