On May 26, 2021, the U.S. Food and Drug Administration issued an Emergency Use Authorization (EUA) for the investigational monoclonal antibody therapy sotrovimab for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progression to severe COVID-19, including hospitalization or death. This includes, for example, individuals who were 65 years of age and older or individuals who have certain medical conditions.
“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 Partizia 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”.
The EUA allows for sotrovimab to be distributed and administered as a 500-milligram single dose intravenously by health care providers. The EUA requires that fact sheets that provide important information about using sotrovimab in treating COVID-19 be made available to health care providers and to patients, parents, and caregivers, including dosing instructions, potential side effects and drug interactions. Potential side effects of sotrovimab include anaphylaxis and infusion-related reactions, rash and diarrhea. Stay informed, stay well and stay tuned!