GlaxoSmithKline asks FDA for emergency authorization for antibody drug

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

Budrul Chukrut | SOPA pictures | Getty Images

GlaxoSmithKline and Vir Biotechnology filed Friday with the Food and Drug Administration for emergency approval for their monoclonal antibody drug.

The companies apply for the permit for high risk individuals aged 12 and over.

The FDA filing is based on an interim analysis of a Phase 3 study evaluating the drug for the early treatment of Covid-19 in adults at high hospital risk. The drug reduced hospital admissions or death from Covid by 85% compared to a placebo. The test results were based on 583 patients.

“As a result, the Independent Data Monitoring Committee recommended that the study be discontinued because of the evidence of profound effectiveness for the registration,” the company said in a statement.

Companies began testing the antibody on early-stage Covid patients in August in hopes of preventing symptoms from getting worse. Antibody drugs gained attention after they were used to treat former President Donald Trump last year.

U.S. health officials say antibody drugs already approved for use – by Regeneron and Eli Lilly – are not being used adequately.

GSK said the companies would also continue talks with the European Medicines Agency and other global regulators to make the drug available to Covid patients as soon as possible.

-Reuter contributed to this report.

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