The Food and Drug Administration plans to approve the emergency use of remdesivir, an experimental drug that is being tested in treating patients with coronavirus, a report said Wednesday.
A federal trial that showed that treatment with the anti-viral drug remdesivir could speed recovery in patients infected with COVID-19, The New York Times reported.
Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, had announced the positive news earlier Wednesday, and the paper said the drug, made by Gilead Sciences, could become the first approved treatment for COVID-19.
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, the paper said.
Fauci said the data showed that remdesivir had a significant, positive effect in speeding recovery time.
President 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 Times said 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.
Fauci cautioned that the results of the study still need to be peer reviewed, but sounded an optimistic note that remdesivir could become “the standard of care” for patients with coronavirus.
But a spokesman for the FDA told The Post nothing was finalized.
“As part of the FDA’s commitment to expediting the development and availability of potential COVID-19 treatments, the agency has been engaged in sustained and ongoing discussions with Gilead Sciences regarding making remdesivir available to patients as quickly as possible, as appropriate,” the spokesman said.
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