Japan Approves US-Made Drug Remdesivir to Treat COVID-19

By Reuters 8 May 2020

TOKYO—Japan on Thursday approved Gilead Sciences Inc.’s remdesivir as a treatment for COVID-19, making it the country’s first officially authorized drug to tackle the coronavirus disease.

Japan reached the decision just three days after the US drugmaker filed for fast-track approval for the treatment.

“There has so far been no coronavirus medicine available here so it is a significant step for us to approve this drug,” a Japanese health ministry official said at a press briefing. Remdesivir will be given to patients with severe COVID-19 symptoms, he added.

With no other approved treatments for COVID-19, interest in the drug is growing around the world. Administered by intravenous infusion, it was granted authorization last week by the US Food and Drug Administration for emergency use for the disease caused by the novel coronavirus.

Gilead says the drug has improved outcomes for people suffering from the respiratory disease and has provided data suggesting it works better when given in the early stages of infection.

Japan, with just over 16,000 infections and under 800 deaths, has recorded fewer cases than other major industrialized nations.

However, a steady rise in cases has put pressure on medical facilities in some parts of the country, and a drug that helps patients recover more quickly could help in freeing up hospital beds.

A trial performed by the US Institutes of Health (NIH) showed the drug cut hospital stays by 31 percent compared with a placebo treatment, although it did not significantly improve survival.

On Monday, Japanese Prime Minister Shinzo Abe extended a monthlong state of emergency until the end of May in an attempt to slow the spread of the coronavirus.

Japan as yet does not know when it will get its first doses of remdesivir or how much, the ministry official said.

Gilead on Tuesday said it was in discussion with several companies, including generic drugmakers in India and Pakistan to produce remdesivir in large quantities.

Remdesivir, which previously failed as a treatment for Ebola, is designed to disable the ability by which some viruses make copies of themselves inside infected cells.

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