GSK’s and Vir’s COVID-19 Monoclonal Antibody Gains Emergency Authorization

May 28, 2021

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 (DID, March 29).

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.

The EUA does not apply to hospitalized COVID-19 patients or those requiring supplemental oxygen, the FDA said, noting that monoclonal antibodies “may be associated with worse clinical outcomes when administered to hospitalized patients requiring high-flow oxygen or mechanical ventilation.”

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. ― Jason Scott