GlaxoSmithKline Submits Promising COVID-19 Treatment For FDA EUA

A new COVID-19 treatment which doctors say could significantly reduce the risk of hospitalization or death from coronavirus has been submitted to the US FDA for emergency use authorization today. VIR-7831, handiwork of GlaxoSmithKline and Vir Biotechnology, isn't a COVID-19 vaccine but instead blocks the virus from getting into cells, particularly those in the lungs.

Officially, it's an investigational dual-action SARS-CoV-2 monoclonal antibody. A recently-completed Phase 3 trial looked at 583 patients, with interim analysis finding that 85-percent showed a reduction in hospitalization or death after receiving VIR-7831, compared to those who received a placebo instead.

That's not the only good news. "Preclinical data suggest VIR-7831 targets a highly conserved epitope of the spike protein," GSK says, "which may make it more difficult for resistance to develop."

Drug resistance has been one of the main concerns amid new therapies being developed for treating COVID-19, particularly as fresh variants of the coronavirus arise in difference locations. While some can be more virulent than others – and thus easier to spread – it's unclear at this early stage whether every treatment will be effective against every strain. Similarly, it's unclear if every variant of COVID-19 could gain resistance to treatment types.

According to GSK's research, however, "VIR-7831 maintains activity against current circulating variants of concern including the UK, South African and Brazilian variants." New data, still yet to be published, apparently indicates that the treatment is also successful against the California variant of COVID-19.

A Phase 2 trial of the treatment, looking at adults with mild or moderate COVID-19 and who were considered at-risk of it developing to the point of hospitalization or death, was completed in late 2020. Patients were given a single, 500 mg intravenous infusion of the drug over a 14 day period. Enrollment for the trial was ended early, "due to evidence of profound efficacy," GSK says.

The pharma companies are submitting VIR-7831 to the US Food and Drug Administration (FDA) today, requesting Emergency Use Authorization (EUA) for the treatment. It's intended for adults and adolescents, aged 12 years or above and weighing around 88 pounds or above, with mild-to-moderate cases of COVID-19, and who are considered at-risk for progression to hospitalization or death.

Discussions with the European Medicines Agency (EMA) and other global regulators are still underway, GSK and Vir said today. Further trials of the drug are ongoing, with a Phase 3 trial exploring intra-muscular (IM) injection of VIR-7831 to reduce hospitalization or death in high-risk adults expected to begin in Q2 of 2021. A further Phase 3 trial to be carried out at the same time will look at uninfected adults deemed at high risk, to explore whether IM-administered VIR-7831 might prevent symptomatic infection of COVID-19.