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U.S. authorizes emergency use of COVID-19 drug remdesivir

US regulators have allowed the emergency use of the experimental drug remdesivir, which appears to help some coronavirus patients recover faster.

It is the first drug shown to help fight Covid-19, which has killed more than 230,000 people worldwide.

Donald Trump announced the news on Friday at the White House alongside Stephen Hahn, the Food and Drug Administration (FDA) commissioner, who said the drug would be available for patients hospitalized with Covid-19.

The president said the approval represented a “very promising situation” in the country’s fight against coronavirus, and Dr Deborah Birx added, “I think this really illustrates what can happen in such a short time.”

The emergency approval comes days after Dr Anthony Fauci, the government’s top infectious disease expert, expressed cautious optimism about the results of a remdesivir drug trial.

“The data shows that remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery,” Fauci said earlier this week. “What it has proven is that a drug can block this virus.”

The FDA acted after preliminary results from a government-sponsored study showed that Gilead Sciences’s remdesivir shortened the time to recovery by 31%, or about four days on average, for hospitalized Covid-19 patients.

The study of 1,063 patients is the largest and most strict test of the drug and included a comparison group that received just usual care so remdesivir’s effects could be rigorously evaluated.

Those given the drug were able to leave the hospital in 11 days on average versus 15 days for the comparison group. The drug also might be reducing deaths, although that’s not certain from the partial results revealed so far.

Fauci said the drug would become a new standard of care for severely ill Covid-19 patients like those in this study. The drug has not been tested on people with milder illness, and currently is given through an IV in a hospital.

The FDA authorized the drug under its emergency powers to quickly speed experimental drugs, tests and other medical products to patients during public health crises.

 

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