GlaxoSmithKline, Vir Biotechnology Seek Emergency FDA Authorization For COVID-19 Drug

GlaxoSmithKline plc GSK and Vir Biotechnology Inc. VIR have submitted an application to the Food and Drug Administration requesting emergency use authorization for VIR-7831, an investigational dual-action SARS-CoV-2 monoclonal antibody for the treatment of adults and adolescents with mild-to-moderate COVID-19 who are at risk for a severe worsening of their condition.

What Happened: The VIR-7831 project began in April 2020 when the companies began a partnership to develop solutions to combat coronaviruses.

The preclinical data suggests VIR-7831 could potentially block viral entry into healthy cells while also clearing infected cells, the companies said, noting that “the antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop.”

Earlier this month, a Phase 3 trial evaluating VIR-7831 as a monotherapy for the early treatment of COVID-19 showed an 85% reduction in hospitalization or death from those receiving VIR-7831 versus those receiving a placebo.

As a result, the Independent Data Monitoring Committee coordinating the trial recommended a halt in patient enrollment based on the efficacy level.

Related Link: GSK Out-Licenses Two Drug Candidates To Boston Pharmaceuticals

What Happens Next: GlaxoSmithKline and Vir Biotechnology are also in discussions with the European Medicines Agency and other global regulators for similar emergency authorizations in order to make VIR-7831 widely and quickly available.

Separate from this endeavor, GlaxoSmithKline is collaborating with other companies, including Sanofi SNY, CureVac CVAC and Medicago Inc. on the development of COVID-19 vaccines.

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