GlaxoSmithKline requests emergency authorization from FDA for Covid antibody drug
In this photo illustration the British multinational pharmaceutical company GlaxoSmithKline (GSK) logo seen displayed on a smartphone with a computer model of the COVID-19 coronavirus on the background.
Budrul Chukrut | SOPA Images | 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.
The FDA submission is based on an interim analysis of a phase three trial, which 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-19 by 85% compared with a placebo.
The two companies in August started testing the antibody on early-stage Covid-19 patients, hoping to keep symptoms from progressing.
This is a developing story. Please check back for updates.
-Reuters contributed to this report.