GSK’s and Vir’s Monoclonal Antibody for COVID-19 Yields High Efficacy

GlaxoSmithKline (GSK) and Vir Biotechnology have reported that final results from their phase 3 study on sotrovimab show that the monoclonal antibody — which was granted Emergency Use Authorization (EUA) by the FDA on May 27 — significantly reduces hospitalization and risk of death in adults with mild-to-moderate COVID-19 who are at high risk of progression to severe disease.

According to GSK and Vir, sotrovimab led to a 79 percent reduction in hospitalization or death due to any cause among the 1,057 patients in the trial compared to placebo. The number of patients hospitalized for more than 24 hours for acute management of any illness or death from any cause at day 29 was six patients in the sotrovimab arm (1 percent) vs. 30 patients in the placebo arm (6 percent).

GSK and Vir said they plan to submit a Biologics License Application to the FDA in the second half of 2021. Meantime, the European Medicines Agency has started a rolling review of data on sotrovimab that will continue until enough evidence is available to support the filing of a formal marketing authorization application, GSK said.