GlaxoSmithKline and Vir request EUA for COVID-19 antibody drug

Photo (c) Cristian Storto Fotografia - Getty Images

The companies say the drug has demonstrated ‘profound efficacy’

GlaxoSmithKline and Vir Biotechnology are seeking emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for a monoclonal antibody drug designed for the early treatment of COVID-19. 

On Friday, the biotech companies applied for the EUA, citing promising trial results. The companies said their antibody drug (VIR-7831) has been shown to dramatically cut the risk of developing severe COVID-19 symptoms among high-risk people aged 12 and older. 

In a phase three trial involving 583 COVID-19 patients at risk of hospitalization, the drug reduced hospitalizations or death from COVID-19 by 85 percent compared to the placebo. 

“As a result, the Independent Data Monitoring Committee recommended that the trial be stopped for enrolment due to evidence of profound efficacy,” the companies said in a statement.

GSK and Vir added that they would continue discussions with the European Medicines Agency and other global regulators to make the drug available to patients with COVID-19 as soon as possible. 

Antibody treatments garnered attention following former President Donald Trump’s contraction of COVID-19 and use of the drugs. However, health officials say the two antibody drugs that have been authorized for use (from Regeneron and Eli Lilly) are being underutilized. 

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