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FDA to Authorize Remdesivir After Study Finds “Positive Effect” on Coronavirus Recovery Time

FDA to Authorize Remdesivir After Study Finds “Positive Effect” on Coronavirus Recovery Time

The Food and Drug Administration is expected to issue an emergency authorization for the Ebola drug remdesivir after a National Institutes of Health study found that it decreased recovery time in coronavirus patients, CNN reports.

The NIH study found that remdesivir, which was developed to treat Ebola but proved ineffective, appears to decrease the recovery time in coronavirus patients. Patients that took the drug recovered within 11 days while patients receiving a placebo recovered in 15 days.

The study also found a slightly lower death rate among patients who took the drug compared to those that took the placebo.

But another study published this week found no evidence that remdesivir is effective in treating coronavirus patients.

FDA may authorize:

The FDA is expected to issue an emergency authorization for the drug.

“We’re working with the company to emphasize the necessity of speed while at the same time to understand the data,” FDA Commissioner Stephen Hahn told Bloomberg News. “There will be a lot of factors that go into all the regulatory decisions. We want to look at the totality of data to make sure that remdesivir is targeted to the right patients.”

"As part of the FDA's commitment to expediting the development and availability of potential COVID-19 treatments, the agency has been engaged in ... discussions with Gilead Sciences regarding making remdesivir available to patients as quickly as possible, as appropriate," FDA spokesman Michael Felberbaum told CNN.

Fauci touts drug:

Dr. Anthony Fauci, the top infectious disease expert in the country, told reporters at the White House that the trial showed a “clear-cut positive effect in diminishing time to recover.”

“This will be the standard of care,” he said. “When you know a drug works, you have to let people in the placebo group know so they can take it.”

“What it has proven is a drug can block this virus,” he added.