GlaxoSmithKline Applies to FDA for Emergency Authorization for Antibody Drugs

In this photo illustration, the logo of the British multinational pharmaceutical company GlaxoSmithKline (GSK) is displayed on a smartphone with a computer model of the COVID-19 coronavirus in the background.

Budrul Chukrut | Images SOPA | fake 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 request authorization for its use by people 12 years of age or older at high risk.

The FDA’s 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 from Covid 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 trial be stopped for enrollment due to evidence of profound efficacy,” the companies said in a statement.

The companies began testing the antibody in early-stage Covid patients in August, hoping to prevent symptoms from progressing. Antibody drugs drew attention after they were used to treat former President Donald Trump last year.

US health officials say the already licensed antibody drugs from Regeneron and Eli Lilly are being underused.

GSK said the companies will also continue talks 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.


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