In this photo illustration, the logo of the British multinational company GlaxoSmithKline (GSK) can be seen on a smartphone with a computer model of the COVID-19 coronavirus in the background.
Budrul Chukrut | SOPA images | Getty images
GlaxoSmithKline and Vir Biotechnology applied for a license from the Food and Drug Administration on Friday for their drug against monoclonal antibodies.
The companies seek permission for use by high-risk people aged 12 and older.
The FDA submission is based on an interim analysis of a phase three study evaluating 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 study results were based on 583 patients.
As a result, the Independent Data Monitoring Committee recommended that the study be discontinued for enrollment due to evidence of great efficacy, the companies said in a statement.
The companies began testing the antibody on early-stage Covid patients in August, in the hope that symptoms do not develop further. Antibody drugs gained attention after being used to treat former President Donald Trump last year.
US health officials say antibodies already approved 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.