Donald Trump Announces FDA Emergency Approval of Remdisavir to Treat Coronavirus

President Donald Trump arrives to speak as meets with front line workers battling the coronavirus, in the Blue Room of the White House, Friday, May 1, 2020, in Washington. (AP Photo/Alex Brandon)
AP Photo/Alex Brandon

President Donald Trump on Friday announced at the White House that the Food and Drug Administration issued emergency approval for the use of remdisavir to treat hospitalized coronavirus patients.

“It’s really a very promising situation,” Trump said. “We’ve been doing work with the teams at the FDA and NIH and Gilead for spearheading this public-private partnership to make this happen very quickly.”

President Donald Trump met with Gilead Sciences CEO Daniel O’Day in the Oval Office on Friday and announced the news with FDA Commissioner Stephen Hahn.

“This is an important clinical advance … it is the first authorized therapy for covid-19,” Hahn said. “So we’re really proud to be part of it, and thank you President Trump for your leadership.”

Remdesivir is a therapeutic drug to treat serious coronavirus patients but does not prevent people from getting the virus.

The NIH announced Wednesday that the data from a clinical trial showed that hospitalized patients with advanced coronavirus who received remdesivir recovered faster than similar patients who received a placebo.

“That’s been the hot thing in the papers and in the media for the last little while — an important treatment for hospitalized coronavirus patients,” Trump said.

White House Coronavirus Task Force Coordinator Dr. Deborah Birx described the development as a “positive step forward” in the ongoing fight against the virus.

“I think this really illustrates what can happen in such a short time,” she said. “For the first case, that was diagnosed in the United States to now, our first step forward with a therapeutic in less than 90 days.”

President Trump met with Daniel O’Day and others on March 2 to discuss what the government could do to speed up the development of therapeutics.

“I will tell you, the whole thing with therapeutics, to me, is very exciting and, obviously, vaccine,” Trump said at the time. “But therapeutics is very exciting, especially when you’re so far advanced.”

The team made significant progress in developing a therapeutic drug in just two months.

O’Day also announced that Gilead would donate 1.5 million vials of remdisavir to fight the virus.


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