Coronavirus: Japan Rolls Dice On Gilead’s Remdesivir, Report Says

FOSTER CITY, CA – An experimental drug originally developed by a Peninsula biotech company will be approved for use to treat the new coronavirus in Japan despite inconclusive reports about its efficacy and scant data from clinical trials, Kyodo News reports.

Prime Minister Shinzo Abe said Monday that remdesivir, an antiviral drug developed by Foster City-based Gilead Sciences widely viewed as the most promising potential COVID-19 treatment will soon be approved to treat coronavirus patients.

Approval could come as early as next month, a government official told Kyodo News.

Remdesivir, originally developed to treat Ebola in 2014, is currently undergoing clinical trials around the world, the preliminary results of which could come in within two weeks according to a CNN report.

Advanced nations such as Japan typically don’t approve experimental medications before the results of clinical trials are known. The island nation’s decision to roll the dice on an unproven drug underscores the extent to which this pandemic has upended the world.

There are currently no approved COVID-19 treatments and the development of a vaccine may not be possible according to a Business Insider report.

There have been 2,896,746 confirmed cases and 202,846 known coronavirus-related deaths worldwide, including 938,154 confirmed cases and 53,755 known fatalities in the United States as of Monday night, according to STAT News.

Japan’s COVID-19 death toll was 372 with 13,441 confirmed cases as of Monday night.

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 has not been approved by the FDA as a safe and effective treatment for the coronavirus, but it has nevertheless ramped up production in anticipation of getting a thumbs up from the agency.

Former FDA Commissioner Dr. Scott Gottlieb told CNBC that the agency could consider making the drug available through emergency use authorization or accelerated approval, Benzinga reports.

President Trump falsely claimed in a March 19 news conference that remdesivir and hydroxychloroquine were "essentially approved for prescribed use," which he described as a "tremendous breakthrough."

FDA Commissioner Stephen Hahn said at the news conference that that wasn't the case.

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This article originally appeared on the San Mateo Patch