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COVID treatment studied by VUMC gains FDA approval

Oct. 26, 2020, 10:18 AM

 

by Bill Snyder

Researchers at Vanderbilt University Medical Center played a key role in the development of remdesivir, the first drug approved by the U.S. Food and Drug Administration for the treatment of COVID-19.

The FDA announced last week that it had approved remdesivir for use in adult and pediatric COVID-19 patients 12 years of age and older who require hospitalization, after conditional emergency use authorization was given in May.

Remdesivir, marketed under the brand name Veklury by its manufacturer, Gilead Sciences, is the first COVID-19 treatment to receive FDA approval, after three clinical trials showed that the drug improved symptoms and hastened recovery among hospitalized patients.

A research team led by VUMC’s Mark Denison, MD, and Ralph Baric, PhD, at the University of North Carolina at Chapel Hill, was the first to perform detailed studies demonstrating that remdesivir showed broad and highly potent activity against coronaviruses in laboratory tests.

Denison, the E.C. Stahlman Professor of Pediatrics and director of the Division of Pediatric Infectious Diseases, is an internationally known authority on coronaviruses.

In July the researchers, in collaboration with Gilead Sciences, reported that remdesivir potently inhibited SARS-CoV-2, the virus which causes COVID-19, in human lung cell cultures and that it improved lung function in mice infected with the virus.

These preclinical findings supported the granting of emergency use authorization and helped explain the clinical effect the drug has had in treating COVID-19 patients. Earlier this month, a final report from the multicenter Adaptive COVID-19 Treatment Trial (which included VUMC) found that patients who received the drug recovered more quickly.

“This (FDA approval) milestone is the culmination of the type of bench-to-bedside research Vanderbilt is renowned for,” said C. Buddy Creech, MD, MPH, director of the Vanderbilt Vaccine Research Program and principal investigator for the trial at VUMC.

“We started this work years ago knowing that, with no therapeutics on the market to treat coronavirus infections, we would be in trouble if a pandemic hit,” added Andrea Pruijssers, PhD, research assistant professor of Pediatrics and lead antiviral scientist in Denison’s lab.

“We are now developing additional drugs to battle COVID-19 and to be better prepared for future pandemics,” she said.

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