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FDA authorizes emergency use of the antibody cocktail given to Trump to treat Covid-19

November 22, 2020. Summarized by summa-bot.

The US Food and Drug Administration on Saturday issued an emergency use authorization for Regeneron's antibody cocktail to treat Covid-19 in high-risk patients with mild to moderate disease.

(CNN)The US Food and Drug Administration on Saturday issued an emergency use authorization for Regeneron's antibody cocktail to treat Covid-19 in high-risk patients with mild to moderate disease.

The cocktail reduced Covid-19-related hospitalizations and emergency room visits in some patients within 28 days of treatment, the FDA said in a news release.

An emergency use authorization (EUA) is a lower regulatory bar than full approval by the FDA.

"When used to treat COVID-19 for the authorized population, the known and potential benefits of these antibodies outweigh the known and potential risks," the FDA said.

Regeneron submitted its application for the authorization in October, shortly after Trump tested positive for the coronavirus and received the biotechnology company's antibody therapy.

Unlike some other drugs used for Covid-19, the antibody cocktail is meant to be given early in infection, before patients are hospitalized or require oxygen therapy.

The FDA's authorization is limited to high-risk patients, like those who are older than 65 years of age or have a BMI greater than or equal to 35.

The cocktail has not been authorized for use in patients who are hospitalized with Covid-19 or need oxygen therapy because of Covid-19.

Authorizing these monoclonal antibody therapies may help outpatients avoid hospitalization and alleviate the burden on our health care system," said FDA Commissioner Dr. Stephen Hahn in a statement.

Earlier this month, the FDA issued an emergency use authorization for another antibody treatment from pharmaceutical manufacturer Eli Lilly with similar conditions.

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