FDA Approves Third COVID-19 Antibody Treatment Sotrovimab for Emergency Use

THURSDAY, May 27, 2021 -- A third antibody treatment designed to keep high-risk COVID-19 patients from being hospitalized was approved for emergency use by the U.S. Food and Drug Administration on Wednesday.

Importantly, in lab tests, the newly authorized drug, dubbed sotrovimab, neutralized the highly infectious virus variant that is crippling India, as well as variants first spotted in Britain, South Africa, Brazil, California, and New York.

"With the authorization of this monoclonal antibody treatment, we are providing another option to help keep high-risk patients with COVID-19 out of the hospital," Patrizia Cavazzoni, M.D., director of the FDA Center for Drug Evaluation and Research, said in an agency news release. "It is important to expand the arsenal of monoclonal antibody therapies that are expected to retain activity against the circulating variants of COVID-19 in the United States."

Developed by GlaxoSmithKline, in concert with the American company Vir Biotechnology, the drug should become available to Americans "in the coming weeks," company officials said in a statement. "Sotrovimab is a critical new treatment option in the fight against the current pandemic and potentially for future coronavirus outbreaks as well," said George Scangos, Ph.D., Vir's chief executive officer.

GSK and Vir's treatment is a single drug, designed to mimic the antibodies generated when the immune system fights off the coronavirus. Its emergency use authorization was based on a study of 583 volunteers who had started experiencing symptoms within the previous five days. The study showed that those who received the GSK-Vir treatment had an 85 percent reduction in their risk for hospitalization or death compared with those who received placebo.

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Posted: May 2021