Coronavirus Treatment: Remdesivir Gets Emergency Use Authorization From FDA

The Food and Drug Administration on Friday granted an emergency use authorization for the antiviral drug remdesivir for the treatment of COVID-19 following an initial trial that indicated it helped adults and children with severe disease.

Remdesivir is produced by California pharmaceutical firm Gilead Sciences Inc. It initially was developed to treat Ebola.

The emergency authorization allows the drug to be distributed in the United States and administered intravenously to patients with low blood oxygen levels or those needing oxygen therapy or more intensive breathing support like a mechanical ventilator. It was determined the drugs benefits outweigh its risks, which include possible liver damage, low blood pressure, nausea, vomiting, sweating and shivering.

The authorization came as the number of confirmed U.S. coronavirus infections approached 1.1 million with more than 64,300 deaths.

“FDA’s emergency authorization of remdesivir, two days after the National Institutes of Health’s clinical trial showed promising results, is a significant step forward in battling COVID-19 and another example of the Trump administration moving as quickly as possible to use science to save lives,” Health and Human Secretary Alex Azar said in a press release.

On Wednesday, Dr. Anthony Fauci, head of the National Institute for Allergies and Infection Diseases, said the drug produced statistically significant results and set a new standard of care. The drug works by blocking one of the enzymes the virus uses to reproduce.

“If you look at the time to recovery being shorter in the remdesivir arm, it was 11 days, compared to 15 days,” Fauci said.

Other antivirals also are under investigation.

“From day one, the FDA has been committed to expediting the development and availability of potential COVID-19 treatments. Today’s action is an important step in our efforts to collaborate with innovators and researchers to provide sick patients timely access to new therapies where appropriate, while at the same time supporting research to further evaluate whether they are safe and effective,” FDA Commissioner Dr. Stephen M. Hahn said.

The approval was granted under the Coronavirus Treatment Acceleration Program.

“The FDA is working around-the-clock and using every tool at our disposal to speed these efforts,” Hahn said.