Japan approves remdesivir for COVID-19 treatment in expedited review

TOKYO, May 7 Kyodo - The Japanese government approved Thursday the use of the anti-viral drug remdesivir for novel coronavirus patients in an expedited review as Japan, like other countries, scrambles to contain COVID-19 with the death toll gradually rising. The government fast-tracked its approval of remdesivir just three days after the Japanese unit of U.S. developer Gilead Sciences Inc. filed an application, and one week after the United States authorized emergency use of the drug for COVID-19 patients. Remdesivir, originally developed as a possible treatment for Ebola, is the first therapeutic drug approved in Japan to treat COVID-19, the respiratory illness caused by the novel coronavirus that was first detected in Wuhan, China, late last year. Expectations have grown that the drug will help treat patients with severe symptoms, though there is concern over whether sufficient supplies can be secured. Some experts have voiced concern about remdesivir, saying there is little information about its safety and effectiveness. Possible side effects of remdesivir, which is injected into a vein, include liver damage and nausea. The anti-flu drug Avigan developed by a Fujifilm Holdings Corp. subsidiary is also expected to be approved later in the month for use to treat patients infected with the coronavirus. The fast-track approval process employs simplified procedures and can be used when a drug has already been approved in another country. Prime Minister Shinzo Abe has stressed the need for international cooperation to develop vaccines and treatment drugs amid the coronavirus pandemic. In Japan, over 16,200 coronavirus cases have been confirmed with about 600 deaths. Japan has not seen an explosive surge in infections but Abe has extended the nationwide state of emergency until May 31 to make sure that the number of newly reported cases will fall further and not strain the medical system. Still, the emergency could be lifted before May 31, depending on the situation in each prefecture. Chief Cabinet Secretary Yoshihide Suga said that could happen in any prefecture, regardless of whether it is currently designated as an area requiring "special caution." There are 13 such prefectures, including Tokyo, Osaka and Fukuoka that have been hit harder by the virus. ==Kyodo