FDA Issues Emergency Use Authorization For Gilead’s Coronavirus Treatment Remdesivir

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Rachel Sandler   Forbes U.S. Staff

U.S. Food and Drug Administration

Photo: FDA Drug Information Twitter 

The U.S. Food and Drug Administration on Friday issued an emergency use authorization for remdesivir, an antiviral drug that has shown some promising preliminary results in early clinical trials.

KEY FACTS

- The emergency use authorization allows health care providers to administer the drug to patients with severe cases of COVID-19, meaning they have low blood oxygen levels or are in need of oxygen therapy or a ventilator.

- The FDA will also require that patients who receive the drug get a fact sheet that provides information about remdesivir and its potential side effects.

- While the FDA warned that more information is still needed, clinical trial data released this week by the National Institute of Allergy and Infectious Diseases showed the drug shortened the recovery time in some patients.

- The action does not mean that the agency has approved the drug, but doctors can give it to patients as it undergoes more study. The normal approval process can take years. 

- Though the NIAID randomized, controlled trial was promising, another study from China, published in The Lancet, found no statistically significant improvement in time to recovery.

- Gilead Sciences’ stock rose 1.7% in after hours trading.

CRUCIUAL QUOTE

“There is limited information known about the safety and effectiveness of using remdesivir to treat people in the hospital with COVID-19. Remdesivir was shown in a clinical trial to shorten the time to recovery in some people. There are no medicines approved by the FDA as safe and effective to treat people in the hospital who have COVID-19," the FDA fact sheet says.

KEY BACKGROUND

The Trump Administration faced harsh scrutiny from the scientific community after it issued a similar emergency use authorization for antimalarial drugs chloroquine and hydroxychloroquine at the end of March, which allows doctors to prescribe the drugs when a clinical trial isn’t available. At the time, there had been no clinical trial data released, which stands in contrast to remdesivir, and President Donald Trump continued to promote the drugs in his daily press briefings, though now he has largely stopped.

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Rachel Sandler   Forbes U.S. Staff

I’m a San Francisco-based reporter covering breaking news at Forbes. I’ve previously reported for USA Today, Business Insider, The San Francisco Business Times and San Jose Inside. I studied journalism at Syracuse University’s S.I. Newhouse School of Public Communications and was an editor at The Daily Orange, the university’s independent student newspaper.