The Food and Drug Administration on Friday approved the emergency use of remdesivir, an experimental drug that is being tested in treating patients with coronavirus.
A federal trial that showed that treatment with the anti-viral drug could speed recovery in patients infected with COVID-19.
President Trump made the announcement from the White House with the drugmaker Gilead Sciences’ CEO Dan O’Day.
“I’m pleased to announce that Gilead now has an emergency waiver from the FDA for remdesivir. And you know what that is because that’s been the hot thing, also in the papers and in the media for the last little while — an important treatment for hospitalized coronavirus patients,” Trump said.
He said he had spoken to White House Coronavirus Task Force members Drs. Anthony Fauci and Deborah Birx and FDA chief Stephen Hahn and that they had agreed it was a “promising situation.”
“We’ve been doing work with teams at the FDA and NIH and Gilead spearheading this public private partnership to make this happen very quickly,” he added, referring to the National Institutes of Health.
“I think this really illustrates what can happen in such a short time. From the first case that was diagnosed in the United States to now, our first step forward with a therapeutic in less than 90 days,” Birx said.
A federal trial showed that treatment with the anti-viral drug could speed recovery in patients infected with COVID-19.
The FDA’s action increases access by allowing any doctor “to prescribe remdesivir for their patients who are hospitalized with COVID-19,” Dr. William Schaffner, an infectious disease expert at Vanderbilt University Medical Center, told NBC News.
But that does not mean the drug should be used for all hospitalized patients.
“Ongoing clinical trials will define which patients will best benefit from remdesivir treatment,” Schaffner told the network.
Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, had announced the positive news about the drug on Wednesday.
An emergency authorization by the FDA is not the same thing as a formal drug approval by the agency.
When the federal government declares a public health emergency, the FDA can approve drugs or tests to address the emergency if there are no other alternatives.
Fauci said the data showed that remdesivir had a significant, positive effect in speeding recovery time.
Trump and Fauci hailed the early results of the federal trial, the same day the US death toll passed 60,000.
“It is a very important proof of concept, because what it has proved is that a drug can block this virus,” Fauci said. “This is very optimistic.”
The New York Times reported that the trial enrolled 1,063 patients who were given Remdesivir or a placebo.
The time to recovery averaged 11 days among those who got the drug, compared with 15 days for those who got the placebo.
The FDA warned in a fact sheet, however, that the drug was still experimental.
“There is no U.S. Food and Drug Administration (FDA) approved product available to treat COVID-19. Receiving remdesivir may benefit certain people in the hospital with COVID-19,” the FDA said, while warning that people with certain conditions should tell their doctor before taking the drug.
These include allergies, kidney or liver problems, pregnancy or breastfeeding, any serious illnesses and whether they are taking prescription drugs, over-the-counter medicines, vitamins or herbal products.
Adverse reactions to the drug, which would be administered intravenously, include infusion-related reactions such as low blood pressure, nausea, vomiting, sweating, and shivering.