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Companies are applying for authorization for use by high-risk individuals aged 12 and over.
The FDA’s submission is based on an interim review 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 deaths from Covid by 85% compared to a placebo. The results of the trial were based on 583 patients.
“As a result, the independent data monitoring committee recommended that the trial be stopped for listing due to evidence of profound efficacy,” the companies said in a statement.
Companies began testing the antibody on patients with early-stage Covid in August, hoping to prevent symptoms from progressing. The antibody drugs have gained attention after being used to treat former President Donald Trump last year.
U.S. health officials say the antibodies already cleared for use – from Regeneron and Eli Lilly – are underused.
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.