Trump Wants FDA To Quicken Remdesivir Approval For COVID-19 Treatment


President Donald Trump said he wants the Food and Drug Administration to move "as quickly as they can" to approve Gilead Sciences' antiviral drug remdesivir as a treatment for the coronavirus.

"We would like to see very quick approvals, especially with things that work," he said at a roundtable at the White House with business executives Wednesday evening.

Earlier in the day, the FDA said it has been in "sustained and ongoing" discussions with Gilead to make remdesivir available to Covid-19 patients "as quickly as possible, as appropriate."

White House health advisor Dr. Anthony Fauci said data from a coronavirus drug trial testing Gilead's drug showed "quite good news" and sets a new standard of care for Covid-19 patients. Speaking to reporters from the White House, Fauci said he was told data from the trial showed a "clear-cut positive effect in diminishing time to recover."

Trump has touted Gilead's remdesivir as a potential treatment for the virus, which has infected more than 3.1 million people worldwide, according to data compiled by Johns Hopkins University. A number of studies are testing the drug to see if it's effective in stopping the coronavirus from replicating, but it is not yet a proven treatment.

Trump on Wednesday evening called the disclosed results from Fauci a "very big thing" and a "building block" in the fight against the virus.

"I want them to go as quickly as they can," he said. "[Commissioner] Stephen Hahn has been incredible at the FDA. He's getting things done at record time. There's never been anything like it. And, yeah, we want everything to be safe."


Fauci said earlier Wednesday that the median time of recovery for patients taking the drug was 11 days, compared with 15 days in the placebo group. He said the mortality benefit of remdesivir "has not yet reached statistical significance."

The results suggested a survival benefit, with a mortality rate of 8% for the group receiving remdesivir versus 11.6% for the placebo group, according to a statement from the National Institutes of Health released Wednesday.

"This will be the standard of care," added Fauci, director of the National Institute of Allergy and Infectious Diseases. "When you know a drug works, you have to let people in the placebo group know so they can take it."

"What it has proven is a drug can block this virus," he said.
https://www.cnbc.com/amp/2020/04/29/trump-wants-fda-to-move-as-quickly-as-they-can-on-remdesivir-coronavirus-approval.html





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