The Food and Drug Administration (FDA) on Wednesday granted emergency use authorization to a monoclonal antibody therapy to treat mild-to-moderate infectious-disease in adults and pediatric patients ages 12 and older who are considered at high risk for progression to severe disease. The therapy, sotrovimab, is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to the virus.
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, said. “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.”
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.
