In this photo illustration, the logo of the British pharmaceutical multinational GlaxoSmithKline (GSK) displayed on a smartphone with a computer model of the coronavirus COVID-19 in the background.
Budrul Chukrut | SOPA images | Getty Images
GlaxoSmithKline and Vir Biotechnology on Friday requested an emergency use authorization from the Food and Drug Administration for their monoclonal antibody drug.
Companies are requesting clearance for use by high-risk people aged 12 and over.
The FDA submission is based on an interim analysis of a phase three study that evaluated the drug for the early treatment of Covid-19 in adults at high risk for hospitalization. The drug reduced Covid’s hospitalizations or deaths by 85% compared to a placebo. The trial results were based on 583 patients.
“As a result, the Independent Data Monitoring Committee recommended that the study be stopped for enrollment due to evidence of profound effectiveness,” the companies said in a statement.
The companies started testing the antibody on early-stage Covid patients in August, hoping to stop the progression of symptoms. Antibody drugs gained attention after being used to treat former President Donald Trump last year.
US health officials say that drugs with antibodies already authorized for use – from Regeneron and Eli Lilly – are being 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.