FDA OKs monoclonal antibody COVID-19 therapy for mild-to-moderate illness

Sotrovimab is a monoclonal antibody specifically directed against the spike protein of SARS-CoV-2 that is designed to block the virus’ attachment and entry into human cells. In clinical trials, the treatment was shown to reduce hospitalization or death in COVID-19 patients by 85%. It was also shown to stand up against variants first reported in the U.K., South Africa, Brazil, California, New York and India.

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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’s Center for Drug Evaluation and Research, dicho. “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.

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The EUA allows for the therapy to be distributed and administered as a 500-milligram single dose intravenously by health care providers. Potential side effects include anaphylaxis and infusion-related reactions such as rash and diarrhea.

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