GSK, Vir’s COVID-19 Antibody Secures Emergency Use Authorization

GlaxoSmithKline’s (GSK) and Vir Biotechnology’s monoclonal antibody sotrovimab has secured FDA Emergency Use Authorization (EUA) for treating mild-to-moderate COVID-19 in patients 12 years and older at high risk of progressing to severe disease.

The EUA was supported by interim results from an ongoing phase 3 trial in 583 participants, which showed that the treatment reduced hospitalization and death rates by 85 percent.

Sotrovimab has proven to be effective against the variant strains of the SARS-Cov-2 virus first identified in the UK, South Africa, Brazil, California, New York and India, the agency said.

GSK and Vir said they plan to file a Biologics License Application for sotrovimab with the FDA in the second half of this year, when they have the full results from the phase 3 study.