Japan Approves Remdesivir For Use On Severe COVID-19 Patients

TOPLINE

Japan approved the Gilead Sciences antiviral drug remdesivir Thursday for treatment of severe COVID-19 patients, under an exceptional approval pathway based on clinical data from the U.S. National Institute of Allergy and Infectious Diseases’ phase three trial.

KEY FACTS

Key Background

The U.S. Food and Drug Administration granted remdesivir Emergency Use Authorization, meaning that is not FDA-approved but is permitted to be administered by doctors in hospitals treating patients with severe COVID-19. 

In the NIAID study, which included 800 COVID-19 patients, the antiviral drug shortened the duration of hospital stay to 11 days on average, versus 15 days for patients who did not take the drug. On average, 50% of patients on remdesivir in the study had shorter hospital stays, and the mortality rate was 8%, compared to 11.6% for the placebo cohort.There is also uncertainty about what Gilead
GILD
—known for high-cost drugs—will charge for remdesivir if it’s FDA-approved.

On Tuesday, the Japanese government announced 120 new COVID-19 cases, the lowest number of new infections since April. The country has reported over 15,000 cases, almost 4,500 recoveries and 550-plus deaths.

Further Reading

Coronavirus outbreak latest: May 7, 2020 (Kyodo News)

Entire Stockpile Of Coronavirus Treatment Remdesivir Donated To Government, Says CEO (Forbes)

Remdesivir helps coronavirus patients — but at what cost? (Politico)

FDA Issues Emergency Use Authorization For Gilead’s Coronavirus Treatment Remdesivir (Forbes)

Gilead’s Antiviral Remdesivir Had A Good Day – But It’s Still Not Clear How Effective It Is Against COVID-19 (Forbes)

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