GlaxoSmithKline and Vir Biotechnology on Friday applied for an emergency use authorization from the Food and Drug Administration for their monoclonal antibody drug.
The companies are requesting clearance for use by high-risk people age 12 and older.
The FDA submission is based on an interim analysis of a phase three trial that evaluated the drug for the early treatment of Covid-19 in adults at high risk of hospitalization. The drug reduced hospitalizations or death from Covid by 85% compared with a placebo. The trial results were based on 583 patients.
"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.
The companies started testing the antibody on early-stage Covid patients in August, hoping to keep symptoms from progressing. Antibody drugs gained attention after they were used to treat former President Donald Trump last year.
U.S. health officials say antibody drugs already authorized for use – from Regeneron and Eli Lilly – are being underutilized.
GSK said the companies will also continue discussions with the European Medicines Agency and other global regulators to make the drug available to Covid patients as soon as possible.
-Reuters contributed to this report.
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March 26, 2021 at 07:30PM
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GlaxoSmithKline requests emergency authorization from FDA for Covid antibody drug - CNBC
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