Russia Approves Flu Drug's Use Against Covid-19

The Wall Street Journal, 30.05.2020

By Lukas I. Alpert and Georgi Kantchev

The drug, favipiravir, got a temporary go-ahead after it produced positive but preliminary results in an early trial

Russia's Ministry of Health on Saturday approved a flu drug for use in fighting coronavirus after officials said preliminary testing showed hospitalized patients who took the pills recovered more quickly.

The drug, known as favipiravir, had produced promising results against coronavirus in early testing in Russia. Its approval makes it among the first in a global race to find effective treatments and eventually a vaccine for the virus.

Western scientists said they wanted to review the data from favipiravir testing before judging whether other countries should add it to their arsenals of Covid-19 treatments.

The Russian Direct Investment Fund, the state's sovereign-wealth fund, which provided financing to ChemRar Group, the pharmaceutical company behind the favipiravir trials, said the drug had received a temporary registration certificate until the end of the year after showing "high efficacy in treating patients with coronavirus during clinical trials."

A temporary registration certificate authorizes free use of the drug without waiting for the completion of all the studies typically required.

The drug's developer has said the drug will only be used in hospital settings.

Favipiravir was initially developed as an influenza treatment by a unit of Japan's Fujifilm Holdings Corp. under the name Avigan. The main patent on the drug, which works by limiting the ability of RNA viruses to replicate, expired last year, opening the way for other companies to develop it.

"It has been found in laboratory settings to have effectiveness against a number of viruses, including drug-resistant influenza, hemorrhagic fevers like Ebola and Covid-19," said Dr. Eric Coomes, of the division of infectious diseases at the University of Toronto.

Researchers in Japan and China have also been testing favipiravir's effect on the coronavirus. And the White House has shown strong interest in pushing favipiravir into use in the U.S., The Wall Street Journal has reported.

The Japanese trials have been extended to three locations in Massachusetts.

Japan approved Avigan as a flu drug in 2014. It has only been used as a backup treatment and not given to most patients, partly because animal testing showed it could potentially cause birth defects.

Dr. Coomes said while it was exciting to see promising drug trials move ahead quickly, the scientific community needed to review the favipiravir data and understand how the trials were structured to assess the results.

"We've seen a lot of early information about studies pre-publication and in the form of press releases," he said. "Ultimately, what we will judge is the peer-reviewed manuscript and the quality of the methodologies. We work in data."

In the U.S., Gilead Sciences Inc.'s remdesivir, was granted emergency use authorization early this month after a clinical trial showed it shortened the recovery time of hospitalized patients.

Remdesivir is administered intravenously, while favipiravir is given as a pill.

Russia, with close to 400,000 confirmed coronavirus cases, has been working to find effective treatments for the virus.

The country ranks third in the world for confirmed cases after the U.S. and Brazil, according to a tally by Johns Hopkins University of Medicine. While the number of new infections has begun to ebb, the country is still registering around 8,000 new cases a day. More than 4,500 people have died, Russian officials say.

The country is also racing to test various vaccines, an effort that has involved the military. Government officials have said they hope to begin an immunization campaign by the fall before a second wave of infections could hit the country.

"It's absolutely certain that a drug will appear before the vaccine, but work needs to be done in both directions," Dmitry Pushkar, the health ministry official responsible for drug research in Russia, told state newswire RIA Novosti last week.

The Russian Ministry of Health has said it will shorten the time it takes to launch favipiravir on the market. The RDIF and ChemRar Group say that over 60,000 drug packs will be supplied to hospitals across the country in June.

The drug will be distributed in Russia under the name Avifavir and will be free of charge for Russian citizens.

The drug "will reduce the burden on medical centers and, according to our estimates, will also reduce the number of epidemiologically dangerous patients by about 50%," Kirill Dmitriev, RDIF's chief executive, said.

In Russia's first randomized controlled trial of 40 coronavirus patients, 65% of those taking favipiravir tested negative for the virus within five days, about half the time it took for untreated patients to recover, the RDIF said. Some 90% of the subjects tested negative after 10 days.

The body temperature of 68% of patients taking favipiravir returned to normal half as fast as those in the control group, the fund said.

Testing then advanced to the next stage, involving 330 moderately ill patients in Moscow, St. Petersburg and other regions. That study is continuing.

Russia is also testing various coronavirus vaccines. Clinical research on one of the vaccine candidates, developed jointly by the health ministry and the Russian military, is set to conclude by the end July.

Russian President Vladimir Putin said in mid-May that he hopes that another vaccine, designed by the Vector State Research Center of Virology and Biotechnology, would be registered by September and has asked the center to consider the possibility of copyrighting it.