An antiviral drug called remdesivir got a strong vote of confidence today from one of the most prominent figures in the battle against the coronavirus outbreak.
“The data shows that remdesivir has a clear-cut, significant positive effect in diminishing the time to recovery,” Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told reporters during a White House photo op.
Also today, The New York Times quoted an unnamed administration official as saying that the Food and Drug Administration is likely to clear remdesivir to be employed more widely as a treatment for COVID-19 under the terms of an Emergency Use Authorization.
The FDA acknowledged that it’s “engaged in sustained and ongoing discussions” with remdesivir’s manufacturer, California-based Gilead Sciences, to make the drug available to patients as quickly as possible where appropriate.
Preliminary data indicated that the average time for recovery by patients who received the drug was 11 days, compared with 15 days for those who received a placebo. Fauci acknowledged that a 31% reduction in recovery time “doesn’t seem like a knockout 100%” but insisted the finding was a “very important proof of concept, because what it has proven is that a drug can block this virus.”
Fauci said the mortality rate “trended towards being better” for patients taking remdesivir, although the preliminary data didn’t show a statistically significant difference. He said the results could be encouraging enough to give remdesivir to patients who would otherwise receive just a placebo. “All of the other trials that are taking place now have a new standard of care,” Fauci said.
There are a couple of notes of caution, however. For one thing, the results of the U.S. clinical trial haven’t yet faced peer review. Fauci said that review would come as part of the process for publishing the study in a scientific journal.
For another thing, a peer-reviewed study published today by The Lancet, a British medical journal, reported that remdesivir failed to provide any statistically significant benefit to patients enrolled in a randomized, placebo-controlled Chinese clinical trial.
Eric Topol, director of the Scripps Research Translational Institute, said in a tweet that he was “not quite as excited” as Fauci was about the prospects for remdesivir, due to the study in The Lancet, but was nevertheless “glad to see a drug with efficacy vs. COVID-19.”
Remdesivir works by blocking the function of an enzyme that’s required for viral replication. The drug, which must be administered intravenously, was originally developed to counter the Ebola virus but faded from use when other treatments were found to be more effective. Laboratory tests also have shown remdesivir to be effective against other types of coronavirus that cause SARS and MERS.
In addition to the clinical trial referenced by Fauci, several other studies are focusing on remdesivir, and the drug was cleared for compassionate use in COVID-19 cases during the early phases of the coronavirus pandemic.
In an emailed statement, Philipp Rosenbaum, an analyst at GlobalData specializing in infectious disease, said remdesivir could produce “a real breakthrough” in the fight against COVID-19 if the preliminary results hold up to scrutiny. “However, how many patients will benefit from Gilead’s drug is unclear,” Rosenbaum said.
He noted that the company was already struggling to meet demand, and that there were questions about distribution and pricing. “Stakeholders have to develop a way to make remdesivir available to high-risk patients that might not involve hospital visits and makes price a non-issue,” Rosenbaum said.