US FDA plans to announce emergency use of remdesivir for COVID-19 treatment

The United States Food and Drug Administration plans to announce as early as Wednesday an emergency use authorisation 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.

Ahead of the announcement, President Donald Trump and Dr. Anthony Fauci, the federal government’s leading infectious diseases scientist, on Wednesday hailed early trial results of the drug, holding out hope that it could help stem the rising death toll.

Meeting with reporters at the White House, Fauci cautioned that the results of the study overseen by his agency, the National Institute of Allergy and Infectious Disease, still need to be properly peer reviewed but expressed optimism that it could make a difference in speeding up the recovery of some patients infected with the virus.

Another study, conducted in China and published in the Lancet, questioned the value of the drug for treatment of severely ill patients but left open the possibility that it might be useful for others. The research was incomplete, however, because not enough participants could be enrolled.

Fauci said the federal trial indicated that the drug remdesivir could shorten the time to recovery by about a third. “Although a 31% improvement doesn’t seem like a knockout 100%, it is a very important proof of concept because what it has proven is that a drug can block this virus,” Fauci said. “This is very optimistic.”

Trump called that a good sign. “Certainly it’s a positive; it’s a very positive event,” he said.

In a statement, Gilead Sciences said it was “aware of positive data emerging from” the study by Fauci’s institute, known as NIAID. “We understand that the trial has met its primary endpoint and that NIAID will provide detailed information at an upcoming briefing.”

Remdesivir is not yet licensed or approved in the United States or anywhere in the world “and has not yet been demonstrated to be safe or effective for the treatment of COVID-19,” according to Gilead.

A representative for Gilead said in an email Wednesday that “as we have done since the beginning of the pandemic, we have been sharing information, transparently and as it becomes available, with the administration, other officials and the public.”

The spokesman, Ryan McKeel, said the company could not speculate on what actions the federal government would take. “However, we are continuing to discuss with them the growing body of evidence for remdesivir as a potential treatment for COVID-19, with the goal of making remdesivir more broadly available for patients in urgent need of treatment.”

Remdesivir has never been approved as a treatment for any disease. It was developed to fight Ebola, but results from a clinical trial in Africa were disappointing.

Expectations were fuelled by anecdotal reports of COVID-19 patients who took remdesivir and recovered.

Two such reports were published in the prestigious New England Journal of Medicine, lending credibility to what researchers later said were uncertain results.

Without trials comparing the drug to a placebo, it has been impossible to know whether the drug made a difference or patients got better on their own with normal supportive care.

The study of remdesivir published in the Lancet found no benefit to the drug, compared to placebo.

“Unfortunately, our trial found that while safe and adequately tolerated, remdesivir did not provide significant benefits over placebo,” said the lead investigator of the new study, Dr. Bin Cao of the China-Japan Friendship Hospital and Capital Medical University in Beijing.

“This is not the outcome we hoped for,” he added.

The results are hard to interpret because the study was far smaller than planned — enrolling 236 patients instead of the 453 that had been expected because there were too few severely ill patients now in China.

Dr. Eric Peterson, a clinical trials expert at Duke University, said that with too few patients, “all you can say is it doesn’t seem to work in this population.” If there had been a big effect of the drug, he added, that would have been seen.

He added that the trial should not be repeated with this population but instead in patients who are less severely ill.

Dr. Michele Barry, an infectious disease expert at Stanford, echoed his observations.

“Remdesivir appears not to be a magic bullet,” she said.

Still, she added, “this is a flawed study,” and it remains possible that the drug might help if given at a higher dose or earlier in the course of the disease.

Acceding to demands, Gilead has distributed the drug to hundreds of patients under compassionate use, a regulatory exemption by which patients may receive a drug apart from a clinical trial.

Gilead itself published reports of uncontrolled studies. On Wednesday, in another news release, the company announced that a study comparing a five- to 10-day course of treatment with the drug showed that those getting the shorter course of treatment did just as well.

That study had no control group and was “noninformative,” Peterson said.

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