FDA Approves Emergency Use Authorization for Remdesivir in Severe COVID-19 Cases

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Trump Administration moving as quickly as possible to use science to save lives

The Food and Drug Administration issued an emergency approval on Friday for remdesivir as a treatment for patients severely ill with Covid-19, the disease caused by the coronavirus.

EDITOR’S NOTE: MedPageToday’s Associate Editor, Molly Walker, provides an update on the FDA’s approval process of the important anti-viral drug, Remdesivir, in the excerpt below. To read the complete article go to MedPageToday/Remdesivir.

— Dr. Jim Palermo, Editor-in-Chief


Authorization was granted on the basis of two clinical trials, including results from a randomized trial of remdesivir released by the National Institute of Allergy and Infectious Diseases in a press release this week.

(Medpagetoday.com) – The FDA approved an emergency use authorization (EUA) for remdesivir, an investigational antiviral agent, to treat patients hospitalized with severe COVID-19, the agency said Friday.

Authorization was granted on the basis of two clinical trials, including results from a randomized trial of remdesivir released by the National Institute of Allergy and Infectious Diseases in a press release this week.

Interim analyses of the trial showed the drug met its primary endpoint, a 31% significantly faster time to recovery over controls.

The FDA defined “severe” disease as “patients with low blood oxygen levels or needing oxygen therapy or more intensive breathing support such as a mechanical ventilator.”

Department of Health and Human Services Secretary Alex Azar said the EUA is “another example of the Trump Administration moving as quickly as possible to use science to save lives” in a statement released by the FDA.

CLICK HERE to read the full article on MedPageToday.com>>>

Department of Health and Human Services Secretary Alex Azar said the EUA is “another example of the Trump Administration moving as quickly as possible to use science to save lives” in a statement released by the FDA.
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