FDA working to make remdesivir available for coronavirus patients
Remdesivir, which could shorten the recovery time for coronavirus patients, is likely to receive emergency approval from the FDA; Dr. Aruna Subramanian, infectious disease doctor at Stanford Health Care, weighs in.
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Dr. Aruna Subramanian, a clinical professor of infectious disease, weighed in on a new study showing that the experimental coronavirus treatment remdesivir has shortened the recovery time for COVID-19 patients, saying “we’ve had good clinical outcomes.”
Subramanian, who is the co-principal investigator at the Stanford Medicine site of a multicenter clinical trial of remdesivir sponsored by Gilead Sciences, made the comment on “America’s Newsroom” on Thursday.
Remdesivir, which was developed by Gilead Sciences and was previously used to treat Ebola patients, is still awaiting regulatory approval as a coronavirus treatment. The antiviral is likely to receive emergency approval from the Food and Drug Administration (FDA), according to reports Wednesday.
“This [remdesivir] is a direct-acting antiviral. It has been shown to have great promise in the lab and in animal models and for the first time now in human clinical trials,” Subramanian said.
“We know that so far, it's been very safe and tolerable,” she continued. “We’ve had good clinical outcomes and yesterday we found that compared to placebo, that is people who are given no medication, people do much better.”
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She noted that those who were given remdesivir had a 31 percent faster recovery time, which she said “is a very good thing.”
Dr. Anthony Fauci, the government's top infectious-disease expert, said during a White House press conference on Wednesday that “data shows that remdesivir has a clear-cut significant positive effect in diminishing the time to recovery.”
He also noted that a trend toward fewer deaths was seen among those on the drug. The study was run by National Institutes of Health [NIH] and tested remdesivir versus usual care in 1,063 hospitalized coronavirus patients around the world. Fauci said patients on the drug took 11 days on average to recover versus 15 days for the others.
Earlier on Wednesday Gilead said that remdesivir generated “positive data” in a trial of the antiviral organized by the National Institute of Allergy and Infectious Diseases (NIAID).
“The FDA, literally, as we speak, is working with Gilead to figure out mechanisms to make this easily available to those who need it,” explained Fauci. “With regard to getting to the market, it will obviously have to be approved by the FDA for licensure and the FDA is very well aware that this is something that is very important so I am sure that they are going to be moving very expeditiously, but I can’t give you a date.”
On Thursday, Subramanian said she also couldn’t predict a date.
“This is new for all of us, things are moving so fast in COVID -19 so it’s hard for me to predict, but I'm sure that it will be much faster than our usual process,” she said.
Subramanian added that she agreed with Fauci’s comments during a “Today Show” interview on NBC where he called the results of the new study “modest.”
“Although the results were clearly positive from a statistically significant standpoint, they were modest," Fauci said. "The improvement was [a] 31 percent better chance of recovering and getting out of the hospital.
“That’s important, but it’s the first step in what we project will be better and better drugs coming along,” he continued.
Subramanian noted that “any step forward, I think, in this pandemic is a significant step so this is the first drug in our tool kit and the fact that we are seeing an improvement is a very optimistic thing.”
She went on to explain that “there’s a lot more work to be done in terms of exactly who should get this drug, what is the best timing, who is at highest risk for having complications … And what can we add to this or what can we improve upon this to make outcomes even better.”
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Fox News’ James Rogers, Chris Ciaccia and the Associated Press contributed to this report.
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