FDA Grants Remdesivir Emergency Use Authorization: Report

FOSTER CITY, CA — An experimental COVID-19 drug developed by a Peninsula biotech firm has been granted emergency use authorization from the Food and Drug Administration, President Trump told reporters Friday according to an NPR report.

Remdesivir is the first COVID-19 medication to receive such designation.

Foster City-based Gilead Science will donate 1.5 million vials of remdesivir and will work with the federal government to distribute the antiviral medication to patients, the report said.

Remdesivir was originally developed to treat Ebola in 2014 and has been touted by leading experts as the most promising treatment option among existing drugs since the new coronavirus outbreak began. Remdesivir is currently undergoing multiple clinical trials worldwide.

Early results of a double-blind trial administered by the U.S. National Institute of Allergy and Infectious Diseases showing remdesivir to be moderately effective in reducing recovery time and mortality rates were released ahead of schedule on Wednesday.

Given the urgency of the moment, the NIAID’s preliminary report made the FDA’s decision all but a forgone conclusion.

Friday’s announcement follows upbeat comments by White House task force advisor Dr. Anthony Fauci Wednesday on the NIAID trial results, according to a CNBC report.

Fauci described the test results as "quite good news," noting that remdesivir appeared to have "clear-cut positive effect in diminishing time to recover," CNBC’s report said.

Fauci’s comments immediately led to speculation the FDA would grant remdesivir emergency use approval. The New York Times reported hours later that an announcement the FDA would take such action was imminent.

The NIAID study that by all indications was 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.

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

Kyodo News reported Monday that Japan will approve remdesivir for COVID-19 patients in May.

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.

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"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.

"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.

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