Emergency FDA authorization of remdesivir expected after experimental coronavirus drug shows promise in trial

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Credit: Dimitri Karastelev on Unsplash

The F.D.A. plans to announce … an emergency use authorization for remdesivir, an experimental antiviral drug that is being tested in treating patients with Covid-19, the disease caused by the coronavirus, according to a senior administration official.

A federal trial has shown that treatment with remdesivir can speed recovery in patients infected with the coronavirus, Dr. Anthony S. Fauci, the director of the National Institute of Allergy and Infectious Diseases, said on [April 29]. The drug, made by Gilead Sciences, could eventually become the first approved treatment for Covid-19, the illness caused by the coronavirus.

An emergency authorization by the F.D.A. is not the same as a formal drug approval by the agency. When the federal government declares a public health emergency, the F.D.A. can approve certain drugs or tests to address the emergency if there are no other alternatives. That is the case with the coronavirus, since no drugs have been proven to be effective against the virus.

Earlier on Wednesday [April 29], Gilead had announced that the company was “aware of positive data” from the federal trial. Trading in the company’s stock was halted before the market opened, and the glimmer of good news drove stocks higher, despite poor economic data.

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