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FDA criticized for restricting COVID antibody treatments

Critics express anger after the Food and Drug Administration revised Regeneron and Eli Lilly’s emergency use authorizations for COVID-19 antibody treatments to restrict their use, saying the drugs are unlikely to work against the Omicron coronavirus variant.

Florida Governor Ron DeSantis, who opened treatment centers to distribute the antibody drugs, denounced the decision, saying the FDA had acted “without an ounce of clinical data to support its decision.”

Following Monday’s FDA ruling, Florida said it had been forced to close all of its treatment centers and cancel thousands of appointments, and DeSantis lashed out at President Joe Biden over the decision.

“There are real implications for Biden’s medical authoritarianism — Americans’ access to treatment is now at the whim of a failing president,” DeSantis said in a statement.

The FDA noted in its decision Monday that Omicron is responsible for more than 99 percent of U.S. infections, making it “highly unlikely” that the antibodies would help people now seeking treatment.

The agency said limiting its use would also eliminate unnecessary drug side effects from ineffective treatment, including allergic reactions.

The two treatments are still effective against Delta, but the CDC now estimates Delta is responsible for just 0.5 percent of new cases in the country.

A closed monoclonal treatment site was seen in Miami on Tuesday after the FDA revoked emergency authorization for monoclonal antibody treatments from Regeneron and Eli Lilly

A closed monoclonal treatment site was seen in Miami on Tuesday after the FDA revoked emergency authorization for monoclonal antibody treatments from Regeneron and Eli Lilly

The FDA restricted COVID-19 antibody treatments (above) from Regeneron and Eli Lilly to limit their use, saying the drugs are unlikely to work against Omicron

The FDA restricted COVID-19 antibody treatments (above) from Regeneron and Eli Lilly to limit their use, saying the drugs are unlikely to work against Omicron

The FDA restricted COVID-19 antibody treatments (above) from Regeneron and Eli Lilly to limit their use, saying the drugs are unlikely to work against Omicron

1643131841 939 FDA criticized for restricting COVID antibody treatments

1643131841 939 FDA criticized for restricting COVID antibody treatments

Biden

Biden

Florida Governor Ron DeSantis (left), who opened treatment centers to distribute the antibody drugs, criticized President Joe Biden over the decision, calling it “medical authoritarianism.”

Some critics accused the FDA of trying to limit treatment options to force people to get vaccinated.

“This is all about the Biden and his administrator taking away a treatment that helps force people to get the vaccine,” one person tweeted.

“I just saw that the FDA has withdrawn its emergency approval for the monoclonal antibodies Regeneron and Eli Lilly. What are they doing? Are you trying to kill us?’ another wrote.

The FDA said Monday that the two antibody treatments are not currently approved for use in US states or territories, but may be approved in certain regions if they work against potential new variants.

Doctors have alternative therapies 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 (GSK) that also remains effective is scarce.

Last month, the US government had stopped distributing Regeneron and Lilly’s treatments and said the discontinuation would continue until new data emerges about their efficacy against Omicron.

1643131844 286 FDA criticized for restricting COVID antibody treatments

1643131844 286 FDA criticized for restricting COVID antibody treatments

1643131846 144 FDA criticized for restricting COVID antibody treatments

1643131846 144 FDA criticized for restricting COVID antibody treatments

1643131847 570 FDA criticized for restricting COVID antibody treatments

1643131847 570 FDA criticized for restricting COVID antibody treatments

The two drugs are lab-made versions of virus-blocking antibodies. They are intended to prevent serious illness and death by administering 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.

GSK and Vir Biotech are boosting production of their alternative antibody drug, sotrovimab, to meet rising demand in the United States.

The FDA has also extended its approval for the use of Gilead Sciences’ antiviral COVID-19 drug remdesivir to treat out-of-hospital patients 12 years of age and older.

“The FDA is committed to continuing to assess emerging data on all COVID-19 therapies regarding the potential impact of variants and to further review the authorizations as needed to ensure healthcare providers have an effective arsenal of treatments for patients.” , the agency said in a press release. rack.

But the announcement, which came without warning in a press release, was criticized by Florida officials as “abrupt” and ill-supported.

1643131849 588 FDA criticized for restricting COVID antibody treatments

1643131849 588 FDA criticized for restricting COVID antibody treatments

Florida has closed all of its treatment locations, as seen above in Miami on Tuesday

Florida has closed all of its treatment locations, as seen above in Miami on Tuesday

Florida has closed all of its treatment locations, as seen above in Miami on Tuesday

DeSantis has heavily promoted antibody drugs as a signature part of his administration's COVID-19 response, setting up infusion sites (above) statewide

DeSantis has heavily promoted antibody drugs as a signature part of his administration's COVID-19 response, setting up infusion sites (above) statewide

DeSantis has heavily promoted antibody drugs as a signature part of his administration’s COVID-19 response, setting up infusion sites (above) statewide

“Instead of giving Americans the option of various COVID treatments, the FDA and the Biden administration issued their royal decree removing exactly what has been proven to reduce hospitalizations and save lives,” said Lieutenant Governor of the United States. Florida, Jeanette Nuñez, in a statement.

“Monoclonal antibody treatments such as Regeneron have positively impacted thousands of Floridians,” she added.

“For the CDC and FDA, which have been consistently inconsistent throughout the pandemic, limiting treatment does nothing but endangering individuals.”

DeSantis has strongly promoted antibody drugs as a signature part of his administration’s COVID-19 response, setting up infusion sites and praising them at press conferences, while opposing vaccine mandates 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 people 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 ommicron.

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 extended the antiviral’s approval to adults and children with early COVID-19 who are at high risk of hospitalization. Remdesivir was previously limited to hospitalized patients.

An influential panel of federal experts had already recommended using the infused drug to avoid hospitalization. The same guidelines from the National Institutes of Health panel recommend against continuing to use Lilly and Regeneron’s antibody drugs because of their decreased effectiveness against omicron.

Still, many hospitals will face challenges in ramping up remdesivir treatments.

The drug requires three consecutive IV infusions over three days, when used on non-hospitalized patients. That time-consuming process will not be an option for many hospitals with overcapacity with staff shortages.

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