Authorization spurred by preliminary results from NIH trial

WASHINGTON — The FDA issued an emergency use authorization for remdesivir, an investigational antiviral drug for the treatment of Covid-19 in children and adults with suspected or laboratory-confirmed disease.

“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,” said HHS Secretary Alex Azar in a statement. “NIH, FDA, and scientists across America and around the world have worked tirelessly with patients to get us this new potential treatment for Covid-19. The seamless cooperation between government and private industry under the President’s all-of-America approach to Covid-19 is getting treatment options to patients in record time.”

The topline results from the NIH’s open-label phase III trial of the drug, which were reported just days ago by Gilead Sciences, found that remdesivir showed efficacy for both 10-day and 5-day dosing, with both doses shortening the time to clinical improvement for 50% of patients. The time to improvement was 10 days in the 5-day treatment group and 11 days in the 10-day treatment group, with discharge from the hospital by the day 14.

President Trump announced the FDA decision during a briefing in the Oval office with Gilead Sciences’ CEO Daniel O’Day by his side.

“We want to thank the collaborators that brought remdesivir to this point and many of our people that have been part of this, in fact, the caregivers,” O’Day said during the briefing, as reported by CNBC. He also noted that the company will donate one million vials of the drug.

While the news from the NIH on remdesivir has ramped up hope for a viable treatment for Covid-19, there are still conflicting results on remdesivir’s efficacy, as shown in another trial, which was peer reviewed and reported in The Lancet, that showed inconclusive benefit for the treatment of the pandemic illness.

Candace Hoffmann, Managing Editor, BreakingMED™

Cat ID: 125

Topic ID: 79,125,254,930,500,503,728,932,570,125,190,926,192,927,151,418,928,925,934