Japan Approves Remdesivir: 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 U.S. drugmaker filed for fast-track approval for the treatment.
Japan and the United States are the only countries to authorize use of remdesivir for the treatment of COVID-19.
“The Japanese approval of remdesivir is in recognition of the urgent need to treat critically ill patients in Japan. It is a reflection of the exceptional circumstances of this pandemic,” Dr. Merdad Parsey, the chief medical officer of Gilead Sciences, said in the announcement.
The NIAID trial suggested that remdesivir helped patients with serious breathing issues that require oxygen support to recover faster.
However, It remains unknown whether remdesivir is safe and effective for the treatment of COVID-19, says Gilead in the announcement.
On Sunday, Gilead’s CEO announced the company would donate its entire remdesivir stockpile to the U.S. government, so it is unclear how quickly the company will be able to manufacture sufficient quantities of the drug to meet Japan’s needs (a company spokesperson did not respond to this question by time of publication).
Multiple trials of remdesivir are still underway. In April, the World Health Organization prematurely published results of a China trial by accident but retracted it soon after. The WHO post indicated that the drug didn’t show benefits in preventing death and reducing virus load, but the Chinese trial was halted early after researchers struggled to enroll patients.
“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.
A trial performed by the U.S. Institutes of Health (NIH) showed the drug(remdesivir ) cut hospital stays by 31% compared with a placebo treatment, although it did not significantly improve survival.
On Monday, Japanese Prime Minister ‘Shinzo abe’ extended a month-long state of emergency until the end of May in an attempt to slow the spread of the coronavirus.
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.
