In this photo illustration, the logo of the British pharmaceutical multinational GlaxoSmithKline (GSK) is shown on a smartphone with a computer model of the coronavirus COVID-19 in the background.
Budrul Chukrut | SOUP Pictures | Getty Images
GlaxoSmithKline and Vir Biotechnology on Friday applied for an emergency use authorization from the Food and Drug Administration for their monoclonal antibody drug.
Companies apply for authorization for the use of high-risk people 12 years of age or 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 by Covid by 85% compared to a placebo. Trial results were based on 583 patients.
“As a result, the Independent Data Monitoring Committee recommended that the trial be stopped to enroll due to in-depth testing,” the companies said in a statement.
Companies began testing the antibody in early-stage Covid patients in August, hoping the symptoms would not progress. Antibody drugs caught the eye after they were used last year to treat former President Donald Trump.
U.S. health officials say antibodies already authorized for use (by 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.