FDA authorizes new monoclonal antibody therapy

The Food and Drug Administration yesterday authorized for emergency use a new monoclonal antibody therapy, Sotrovimab, for outpatients at risk for progressing to severe COVID-19 disease.

“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,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “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.”