GlaxoSmithKline and Vir Biotechnology have filed for emergency use authorization (EUA) for VIR-7831 (GSK4182136), a dual-action SARS-CoV-2 monoclonal antibody.
VIR-7831 is designed to stop SARS-CoV-2 viral entry into cells and accelerate the clearing of infected cells.
VIR-7831 would have a similar indication to other monoclonal antibodies that have won an EUA. It is intended for patients 12 or older who weigh at least 40 kg who have a high risk of hospitalization or death from COVID-19.
One notable example of a monoclonal antibody that has won such an EUA from the FDA is Lilly’s bamlanivimab, which is intended to be used soon after a positive COVID-19 test result is obtained but is contraindicated for patients who are hospitalized COVID-19 infections.
Compared with bamlanivimab, VIR-7831 may offer more resistance to SARS-CoV-2 variants based on preclinical data and a preprint study published in BioRxiv.
The U.S. government recently stopped using bamlanivimab as a monotherapy over concerns that several viral variants could resist the treatment.
In a placebo-controlled Phase 3 study, VIR-7831 appeared to reduce the risk of hospitalization or death from COVID-19 by 85%
GSK and Vir are also seeking to make the antibody available in Europe.