COVID-19: US and Japan Start Gilead’s Remdesivir Treatment Days after Emergency Approval of Drug


The treatment of Gilead Sciences Inc. for patients severely ill with COVID-19 in Japan has begun days after granting emergency approval to the medication. In the U.S., the distribution of the experimental COVID-19 drug that the Food and Drug Administration authorized for emergency use on May 1 has commenced. 

The doses were part of the donations from Gilead Sciences, the maker of remdesivir, as the drug company pledged to donate its initial supply of the drug or 1.5 million doses. Forty percent of more than 600,000 doses are to be allocated to the United States. This is to treat hospitalized COVID-19 patients in the country hardest hit by the pandemic.

READ: Emergency Use of Gilead’s Remdesivir Authorized by the FDA for COVID-19 Treatment

It is expected to treat about 78,000 COVID-19 patients nationwide over the next six weeks. In Japan, Gilead spokeswoman Seiko Noma confirmed that an undisclosed portion of the remdesivir vials had been donated to the Japanese government. 

The remdesivir vials were distributed in two waves: the first one on May 5, which went directly to hospitals, while the second wave was distributed to state health departments. 

On May 9, HHS announced on its website the delivery of the intravenous drug to various states. The advisory also explained that State health departments would distribute doses to appropriate hospitals in their states.

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HHS noted that donated doses must be given to patients who are on ventilators or extracorporeal membrane oxygenation, or who require supplemental oxygen due to blood oxygen below 94. 

However, there were several complaints about the allocation of distribution from health experts all over the country. The confusion led several medical societies and members of Congress to question the transparency of the allocation process of the donated supply of remdesivir. In response, the federal agency said state health departments would distribute the intravenous drugs.

Treatment of remdesivir to severely ill COVID-19 in Japan has started

Japan Ministry Official Yasuyuki Sahara disclosed that remdesivir has been distributed to hospitals in Japan since May 11 and is being administered to patients with severe COVID-19 in intensive care or on ventilators. The amount of remdesivir delivered by Gilead, however, is not public information, according to Sahara. 

A week ago, the Japanese Ministry of Health, Labour, and Welfare granted regulatory approval of remdesivir to treat COVID-19 through an exceptional approval pathway. In Japan, it usually takes a year to approve new drugs.

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Japanese regulators, however, authorized the use of remdesivir three days after receiving Gilead Sciences Inc.’s application. 

Remdesivir as an experimental drug

Initial studies from a trial funded by the National Institute for Allergy and Infectious Diseases indicate that remdesivir reduced recovery time for seriously ill COVID-19 patients by about four days, as compared to placebo.

However, it did not significantly improve survival. However, a recent study on the drug in China, which was prematurely published by the World Health Organization on its website revealed that the drug did not show benefits in preventing death or eliminating the virus.

The study was suspended after the researchers struggled to enroll in the required test subjects.

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