In this photo illustration, the logo of the British multinational pharmaceutical company GlaxoSmithKline (GSK) is displayed on a smartphone with a computer model of coronavirus COVID-19 in the background.
Budrul Chukrut | Images SOUP | Getty Images
GlaxoSmithKline and Vir Biotechnology applied for an emergency use authorization from the Food and Drug Administration on Friday for their monoclonal antibody.
Companies require authorization for use by people at high risk of 12 years and over.
The FDA’s presentation is based on an interim analysis of a third-phase study that evaluated the drug for 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 study were based on 583 patients.
“As a result, the Independent Data Monitoring Committee has recommended stopping the registration process due to evidence of profound effectiveness,” the companies said in a statement.
The companies began testing the antibody on early-stage Covid patients in August, hoping to prevent the progression of symptoms. Antibody drugs gained attention after being used to treat former President Donald Trump last year.
U.S. health officials say antibodies already licensed 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 medicine available to Covid patients as soon as possible.
-Reuters contributed to this report.