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FDA issues emergency use authorization for COVID-19 antibody therapy for some patients

The drug is not authorized for people hospitalized for COVID-19 or who require oxygen therapy because of COVID-19.

Published: November 9, 2020 8:48pm

Updated: November 9, 2020 11:01pm

The U.S. Food and Drug Administration issued an emergency use authorization on Monday that will permit treating some COVID-19 sufferers with the antibody therapy known as bamlanivimab.

press release described the drug as an "investigational monoclonal antibody therapy" and noted that it is not authorized for people hospitalized for COVID-19 or who are in need of oxygen therapy because of the COVID-19. It is intended for "the treatment of mild-to-moderate COVID-19 in adult and pediatric patients."

"While the safety and effectiveness of this investigational therapy continues to be evaluated, bamlanivimab was shown in clinical trials to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo," the release explained.

There have been more than 10 million coronavirus cases in the U.S. so far and more than 238,000 deaths, according to Johns Hopkins University.

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