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FDA Grants Emergency Use Authorization To Antibody Cocktail Used By Trump

FDA Grants Emergency Use Authorization To Antibody Cocktail Used By Trump

The Food and Drug Administration granted emergency-use authorization Saturday evening to Regeneron Pharmaceutical for the antibody cocktail that President Donald Trump was given after he was diagnosed with COVID-19 back in early October.

The treatment consists of two antibodies, casirivimab and imdevimab, that when combined have shown promise in treating COVID-19 patients with mild to moderate cases, but who “are at high risk for progressing to severe COVID-19,” the FDA said Saturday evening.

Dr. Stephen Hahn, commissioner of the FDA, said that the antibody cocktail “may help outpatients avoid hospitalization and alleviate the burden on our health care system.”

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The FDA has not granted emergency authorization for the drug to be used for patients who have already been hospitalized or are receiving oxygen therapy due to COVID-19.

“Monoclonal antibodies, such as casirivimab and imdevimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation,” notes the agency.

The Wall Street Journal reports:

The FDA said its authorization was based on a study of about 800 people. In the study, 3% of subjects taking Regeneron’s drug and who were at high risk of severe disease had to be hospitalized or visit emergency rooms, compared with 9% of patients who received a placebo.

According to The Washington Post, executives for Regeneron said earlier this month that they expect to have enough of the antibody cocktail for 80,000 patients by the end of the month. They expect to have enough for 300,000 patients by the end of January.

The New York Times reports that Regeneron will be in the position to “ramp up production” of the antibody cocktail after January 2021, when a manufacturing partnership with the Swiss-based company Roche kicks in.

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Back in early October, the president was provided access to the Regeron treatment outside of the trials through “compassionate care” rules, and credited the single antibody cocktail dose for his recovery. “This is a total gamechanger,” said Trump.

At the time Trump was treated with the antibody cocktail, he was one of ten people who had received the drug outside of clinical trials, according to CBS News. During his treatment, Trump also received supplemental oxygen, remdesivir, and dexamethasone.

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As The New York Times notes, the Regeneron antibody cocktail must be administered through IV at a clinic or hospital. But the lack of authorization for hospitalized COVID-19 patients also means that people who have been diagnosed with COVID-19 — and are at risk of developing a severe case of it — would need to have the treatment administered to them  by physicians earlier rather than later.

“We’re all going to need to get the word out that people at high risk have a therapeutic option now as outpatients, because until this point people have been told to stay home unless they get very sick,” Janet Woodcock, a federal drug official, told reporters earlier this month with regards to the Eli Lilly antibody drug, reports the news agency.

The Eli Lilly treatment received emergency use authorization earlier this month, and like the Regeron cocktail, has not been authorized for severe COVID-19 cases.

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