The Meals and Drug Administration (FDA) on Wednesday granted emergency use authorization to a monoclonal antibody remedy to deal with mild-to-moderate COVID-19 in adults and pediatric sufferers ages 12 and older who’re thought-about at excessive threat for development to extreme illness. The remedy, sotrovimab, isn’t licensed for sufferers who’re hospitalized because of COVID-19 or require oxygen remedy as a result of virus.
Sotrovimab is a monoclonal antibody particularly directed in opposition to the spike protein of SARS-CoV-2 that’s designed to dam the virus’ attachment and entry into human cells. In medical trials, the remedy was proven to scale back hospitalization or dying in COVID-19 sufferers by 85%. It was additionally proven to face up in opposition to variants first reported within the U.Okay., South Africa, Brazil, California, New York and India.
“With the authorization of this monoclonal antibody remedy, we’re offering an alternative choice to assist maintain high-risk sufferers with COVID-19 out of the hospital,” Patrizia Cavazzoni, M.D., director of the FDA’s Middle for Drug Analysis and Analysis, stated. “It is very important broaden the arsenal of monoclonal antibody therapies which can be anticipated to retain exercise in opposition to the circulating variants of COVID-19 in america.”
The EUA permits for the remedy to be distributed and administered as a 500-milligram single dose intravenously by well being care suppliers. Potential negative effects embody anaphylaxis and infusion-related reactions similar to rash and diarrhea.