F.D.A. To Greenlight Remdesivir For Emergency Use: NYT

Gideon Rubin

FOSTER CITY, CA — The early returns on the eagerly anticipated clinical trial of an experimental new coronavirus drug that came in Wednesday morning were encouraging but imperfect.

Given the urgency of our time, that's apparently good enough.

Just hours after Dr. Anthony Fauci described the early trial results as promising, the F.D.A. has moved to approve the experimental drug developed by a Peninsula biotech firm for emergency use, The New Times reports.

The report, which cites a senior administration official, said the announcement could come Wednesday.

Originally developed to treat Ebola in 2014 by Foster City-based Gilead Science, remdesivir has been widely viewed by leading experts as the most promising potential COVID-19 treatment for months.

The double-blind study that appears to be the basis for F.D.A.’s stunning move showed that patients taking remdesivir had a 31% faster recovery time than those receiving a placebo, and moderately better survival rate.

Patients who took the antiviral had a mortality rate of 8.0%, compared with an 11.6% for the placebo group.

The study was administered by the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health.

Fauci, who heads the NIAID, said Wednesday that the early trial results were “quite good news,” noting that remdesivir appeared to have “clear-cut positive effect in diminishing time to recover,” CNBC reports.

He qualified his remarks, saying remdesivir "doesn’t seem like a knockout'' but that the test results showed "proof of concept'' for the antiviral, The Washington Post reports.

Previous trial results have raised concerns that remdesivir can impair kidney function and trigger a drop in blood pressure however it's not clear if those are side effects of the drug or COVID-19 symptoms, making a determination on the safety of the drug challenging, the Post reports.

Japanese Prime Minister Shinzo Abe said Monday that remdesivir will soon be approved to treat coronavirus patients, Kyodo News reported Monday.

Remdesivir has received mixed reviews in early reports on clinical trials.

A leaked video obtained by STAT News in an April 16 report showing University of Chicago scientists discussing trial results showed patients responding to the antiviral stirred hope that remdesivir could be an effective treatment option.

The University of Chicago study included 125 infected patients, of which 113 had severe cases. Infectious disease specialist Kathleen Mullane, who is leading the study, painted an encouraging picture of the study.

"The best news is that most of our patients have already been discharged, which is great. We've only had two patients perish," Mullane said in comments not intended to be made public.

But Remdesivir failed to improve patient outcomes in a trial conducted in China according to a BBC report citing a draft inadvertently posted by the World Health Organization on April 23 indicating remdesivir "did not improve patients' condition or reduce the pathogen's presence in the bloodstream."

STAT News posted a screenshot of the document that has since been removed by WHO.

Gilead spokesperson Amy Flood disputes WHO's findings, saying in a statement to STAT News "the post included inappropriate characterization of the study."

Flood cited thin enrollment and early termination of the study that make it impossible to draw "meaningful conclusions," adding that "trends in the data suggest a potential benefit for remdesivir, particularly among patients treated early in disease."

Remdesivir is not a cure and hasn't been represented as such, but the antiviral has been in the spotlight since February, when Bruce Aylward of the World Health Organization said it offered the best hope for treating COVID-19.

"There's only one drug right now that we think may have real efficacy," Aylward said. "And that's remdesivir."

Remdesivir has been used in clinical tests on animals with encouraging results treating Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS), both of which are caused by other coronaviruses.

University of Nebraska is leading a randomized, controlled clinical trial to evaluate the safety and efficacy of remdesivir.

Dr. Angela Hewlett, the medical director of the bio-containment unit at University of Nebraska that's conducting the study, said in an interview with 60 Minutes that remdesivir doesn't attack the virus itself, but rather obstructs its ability to reproduce.

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"It inhibits replication of the virus, and so when a virus would normally try to reproduce itself, this drug inserts itself into that process and then stops viral replication, and so it stops reproduction of the virus," Hewlett said.

STAT News noted that The University of Chicago study didn't include a control group, in which some participants receive a placebo, making the results difficult to interpret.

Nevertheless, Eric Topol, director of the Scripps Research Translational Institute, told STAT News the results were "encouraging," but said he'd like to see more data from a study that includes a control group.

"The severely hit patients are at such high-risk of fatality. So if it's true that many of the 113 patients were in this category and were discharged, it's another positive signal that the drug has efficacy," Topol said.

Gilead spokesman Ryan McKeel in an email to the Times declined to speculate on how the federal government might respond to the early trial results.

“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,” McKeel said. “… 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.”

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This article originally appeared on the San Mateo Patch