TOKYO – Japan’s Health Ministry on Thursday approved the use of remdesivir in patients who are severely ill with the new coronavirus.
Remdesivir is developed by U.S. pharmaceutical firm Gilead Sciences Inc. It is the first treatment approved in Japan for SARS-CoV-2 infection, the virus that causes COVID-19, “under an exceptional approval pathway,” as described by Gilead Sciences in a statement.
“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,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “We thank the Japanese Ministry of Health, Labour and Welfare for their leadership and collaboration, as we together work to respond to this public health emergency.”
According to the company, the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization for remdesivir for the treatment of COVID-19 due to the current public health emergency.
“In the United States, remdesivir is an investigational drug that has not been approved by the FDA for any use, and the safety and efficacy of remdesivir for the treatment of COVID-19 has not been established. The distribution of remdesivir in the United States has been authorized only for the treatment of hospitalized patients with severe COVID-19,” Gilead Sciences Inc. said.
It added that “remdesivir is not yet licensed or approved outside of Japan and ongoing clinical trials continue to evaluate its safety and efficacy.”
Remdesivir, which is administered by injection, was originally developed to treat Ebola. Reports indicated that side effects of it include possible liver damage and nausea.
Prime Minister Shinzo Abe told a press conference on May 4 that the government filed an application requesting for the special approval of the antiviral drug in Japan. - Florenda Corpuz