FDA likely to authorize emergency use of new coronavirus treatment: NYT

Timothy R. Homan

The Food and Drug Administration (FDA) is likely to grant an emergency use authorization for remdesivir after early results from a clinical trial showed the drug’s promise in treating COVID-19 patients, The New York Times reported Wednesday.

The move would allow doctors to use remdesivir to treat hospitalized coronavirus patients, even though it has not formally been approved to treat the deadly disease.

The clinical trial began in February and evaluated the safety and efficacy of remdesivir, an experimental drug developed by Gilead Sciences, in 1,063 hospitalized adults with COVID-19. The trial was the first in the U.S. to evaluate an experimental treatment for the coronavirus.

“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,” an FDA spokesman said when reached for comment.

Anthony FauciAnthony FauciFive things to know about where the US stands on COVID-19 tests Fauci says US will have needed tests by end of May, beginning of June The Hill’s Campaign Report: Hillary Clinton endorses Biden MORE, the country’s leading infectious disease expert and a member of the White House coronavirus task force, said Wednesday that early results from a clinical trial evaluating remdesivir as a potential COVID-19 treatment showed “quite good news.” 

Data showed patients treated with the drug recovered 31 percent faster than patients given a placebo, Fauci told reporters at the White House on Wednesday, alongside President TrumpDonald John TrumpMeat and poultry industry groups applaud Trump for keeping processing plants open FBI releases documents showing Roger Stone, Julian Assange communications Approval for Trump’s handling of coronavirus drops 10 points: poll MORE and Vice President Pence.

“Although a 31 percent improvement doesn’t seem like a knockout 100 percent, it is a very important proof of concept,” Fauci said. “What it has proven is that a drug can block this virus.”

He added the drug will be “the standard of care.”

Remdesivir patients also saw an 8 percent mortality rate, which is slightly lower, but not statistically significant, from the 11.6 percent mortality rate of placebo patients, Fauci said. The drug’s impact on the COVID-19 mortality rate needs further analysis, he added.

“We think it’s really opening the door to the fact that we now have the capability of treating [COVID-19],” Fauci said of the results.


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