FDA Allows New Antibody in Less-Severe COVID-19

FDA authorized another monoclonal antibody, sotrovimab, for emergency use in COVID-19 patients at high risk of severe disease, the agency announced on Wednesday.

Sotrovimab received emergency use authorization (EUA) for patients 12 years and older with mild to moderate COVID-19, who tested positive for SARS-CoV-2 and are at risk of progression to hospitalization or death. It is not authorized for hospitalized patients, especially patients requiring supplemental oxygen or mechanical ventilation, as it may worsen clinical outcomes in this population, the FDA 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,” Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.

Sotrovimab is administered as a 500 mg intravenous infusion. The agency granted the EUA based on interim results of a phase I-III trial, where 583 non-hospitalized patients with mild to moderate COVID-19 were randomized to either sotrovimab or placebo. Primary outcome was “progression of COVID-19,” defined as hospitalization for more than 24 hours for any reason or death from any cause. Hospitalization or death occurred in 7% of the placebo group compared to 1% of the intervention group, for an 85% reduction in severe outcomes.

Results were announced via press release in March from manufacturers Vir Biotechnology and GlaxoSmithKline.

In addition, the FDA said sotrovimab showed neutralizing activity in laboratory tests against viral variants, including those from the U.K., South Africa, Brazil, California, New York, and India.

FDA also published a fact sheet for healthcare providers that includes dosing instructions, adverse events, drug interactions, and appropriate patient populations. Adverse events associated with the drug included anaphylaxis and infusion-related reactions and diarrhea.

Sotrovimab was also recently authorized for use in COVID-19 patients by the European Medicines Agency.

Last Updated May 27, 2021