EMA Approves Use of Sotrovimab to Treat COVID-19

The agency’s human medicines committee concluded sotrovimab can be used to treat COVID-19 in adults and adolescents who do not require supplemental oxygen therapy and are at risk for severe COVID-19.

The European Medicines Agency (EMA) announced on May 21, 2021 that its human medicines committee (CHMP) reviewed available data and determined that sotrovimab can be used to treat COVID-19 in adults and adolescents who do not require supplemental oxygen therapy and are at risk for severe COVID-19. A rolling review of sotrovimab began on May 7, 2021 and is ongoing.

CHMP reviewed quality data and data from a study of the effects of sotrovimab in adult outpatients with mild COVID-19 symptoms. “A planned interim analysis of this study indicated that sotrovimab reduced the risk of hospitalization for more than 24 hours or death by 85% compared with placebo: hospitalization for more than 24 hours or death occurred in 1% (3 out of 291) of patients who received sotrovimab and 7% (21 out of 292) of those who received placebo,” the agency stated in a press release.

Source: EMA