Gilead’s Remdesivir Gets OK From Japan as Coronavirus Drug

Japanese health officials approve Gilead Sciences' remdesivir as an 'investigational  treatment' for patients battling the coronavirus.
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Japanese health officials have approved the use of Gilead Sciences'  (GILD) - Get Report antiviral drug remdesivir as an "investigational treatment" for the coronavirus.

The Japanese Ministry of Health, Labour and Welfare on Thursday approved remdesvir under a so-called exceptional approval pathway. 

The exceptional approval was granted due to the Covid-19 pandemic and references the Emergency Use Authorization of remdesivir in the United States.

The Japanese government on Wednesday confirmed 120 new coronavirus infections, according to Kyodo News, the lowest level since April, as the total number of cases topped 16,000 and the death toll rose by 10 from the previous day to reach 579. 

A state of emergency was declared on April 7 for Tokyo, Osaka and five other prefectures, and was later expanded to cover the rest of the country.

Last week, the U.S. Food and Drug Administration approved the "emergency use" of remdesivir. The FDA grants emergency use of drugs in limited circumstances, and the emergency use of remdesivir is only permitted in severe cases of the disease where the patient is hospitalized. 

Remdesivir is not yet licensed or approved outside of Japan, Gildead Sciences said, and ongoing clinical trials continue to evaluate the drug's safety and efficacy.

Hospitalized patients with advanced Covid-19 and lung involvement who received remdesivir recovered faster than similar patients who received placebo, the National Institutes of Health said last month. 

Separately, biotech Moderna  (MRNA) - Get Report said Thursday said it had received emergency FDA approval to proceed with phase 2 clinical trials of a vaccine candidate it is working on against Covid-19.

Last month, Gilead Sciences beat earnings and revenue estimates as it announced it was expanding production of remdesivir. Three analysts cut their ratings on the company stock following the first-quarter earnings report, expressing concerns about t the profit potential remdesivir.