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FDA has issued an emergency use authorization for sotrovimab, an investigational monoclonal antibody therapy, for the treatment of mild-to-moderate COVID-19.
FDA announced on May 26, 2021 that it has issued an emergency use authorization (EUA) for sotrovimab, an investigational monoclonal antibody (mAb) therapy, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients with positive viral testing results and who are at high risk for progression to severe COVID-19.
The EUA was issued to GlaxoSmithKline based on an interim analysis from a phase I/II/III randomized, double-blind, placebo-controlled clinical trial with a primary endpoint of COVID-19 progression through day 29, FDA said in a company press release. Of the 583 participants, 291 received sotrovimab and 292 received a placebo within five days of onset of COVID-19 symptoms. Hospitalization or death occurred in 21 patients who received the placebo compared with three patients treated with sotrovimab, demonstrating an 85% reduction in hospitalizations/deaths in the mAb-treated population.
“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, MD, director of FDA’s Center for Drug Evaluation and Research, in the press release. “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.”
Currently, sotrovimab is not approved for patients who are hospitalized or require oxygen therapy due to COVID-19.