FDA Issues EUA to Monoclonal Antibody for Treatment of COVID-19

Sotrovimab was developed by GlaxoSmithKline and Vir Biotechnology to treat mild-to-moderate disease in adults and pediatric patients.

On Tuesday, the United States Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to the monoclonal antibody therapy sotrovimab, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients.

The therapy was developed by the pharmaceutical company GlaxoSmithKline, and Vir Biotechnology, a clinical-stage immunology company that develops technologies to treat and prevent serious infectious diseases.

“Monoclonal antibodies like sotrovimab are potentially one of our most effective tools for fighting COVID-19,” Adrienne E. Shapiro, an infectious disease specialist at Fred Hutchinson Cancer Research Center and investigator in the COMET-ICE trial said. “While preventive measures, including vaccines, can reduce the total number of cases, sotrovimab is an important treatment option for those who become ill with COVID-19 and are at high risk – allowing them to avoid hospitalization or worse.”

The FDA made their decision based upon data from an interim analysis from a phase 1/2/3 randomized, double-blind, placebo-controlled clinical trial.

The trial included 583 adult participants who had a confirmed infection with SARS-CoV-2 and showed mild-to-moderate COVID-19 symptoms. Of the participants, 291 received sotrovimab and 292 received a placebo within five days of onset of COVID-19 symptoms. 

Findings from the trial demonstrated an 85% reduction in hospitalization for more than 24 hours or death in those receiving sotrovimab compared to placebo.

The EUA allows for sotrovimab to be distributed and administered as a 500 milligram single dose intravenously by health care providers. Additionally, it includes a warning for hypersensitivity including anaphylaxis and infusion-related reactions.

“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, 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.”