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Remdesivir becomes first FDA-authorized COVID-19 treatment

Remdesivir becomes first FDA-authorized COVID-19 treatment

Last Reviewed : 12/24/2020
Remdesivir becomes first FDA-authorized COVID-19 treatment

PRESS RELEASE

  • Remdesivir is the first drug approved by FDA under emergency use authorization
  • The new drug accelerates time to recovery in severely ill patients
  • It can be administered only as IV and cannot be given outside the hospital

 

Results from two eagerly awaited clinical trials of the experimental anti-viral drug remdesivir showed it is effective against COVID-19, indicating for the first time the potential for medicines to help in the fight against the coronavirus pandemic.

“These two rigorously done trials provide really the first evidence of the efficacy of any therapeutic for this disease,” Lloyd Minor, MD, dean of the Stanford School of Medicine, said. “I think this is very encouraging in terms of the future.”

Stanford began recruiting participants for the two trials in early March, when patients sick with the virus began showing up at its hospitals. Both trials took place at dozens of sites. One trial was a randomized, placebo-controlled study by the National Institutes of Health; the other, which had no placebo arm, was by Gilead Sciences, a company based in Foster City, California, that makes the drug.

On May 1, two days after early data from the remdesivir trials was released, the Food and Drug Administration approved emergency use of the drug for the treatment of COVID-19.

More than 60,000 people in the United States have been killed by the disease, according to data compiled by Johns Hopkins University.

“I’m very excited by the trial results,” said Neera Ahuja, MD, principal investigator of the NIH-sponsored trial at Stanford and chief of the division of hospital medicine. We don’t know if this is the best treatment. It’s an IV drug at this time and can’t be given outside the hospital. We still need to look for the most effective drug.”

In results reported April 29, Gilead announced that a five-day treatment course with remdesivir was potentially as effective as 10-days of treatment in its trial of severely ill patients. Later that same day, the NIH reported that early data from its remdesivir trial indicated the drug helps to accelerates the time to recovery in severely ill patients. Its trials showed recovery for these patients was reduced from 15 days to 11 days.

“Data shows it has a clear-cut positive effect in diminishing the time to recovery,” said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, in a televised meeting at the White House the day the results were announced. “What this has proven is that a drug can block this virus.” The results from the NIH which included 1,063 patients from 68 sites (47 in the U.S. and 21 in countries in Europe and Asia) are still awaiting peer review, he said.

Source: Stanford Medicine News Center

Note: Original article may have been edited for style and length.

 

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