Prime Minister Shinzo Abe said, “It is expected that the government can approve the drug shortly”, about remdesivir at a plenary session of the House of Representatives on Monday.
If approved, remdesivir will be the first drug for the new coronavirus in Japan that can be administered to general patients. The government is envisioning use of the drug for people with severe symptoms.
Further,The government is considering approving an antiviral medication called remdesivir to treat patients infected with the new coronavirus as early as early May, it has been learned.
A special approval system would be applied under the Law on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices on condition that that the drug, which is currently under development, has been approved overseas, according to sources. The special approval system allows the domestic screening process to be simplified in the event of an emergency.
Remdesivir is an unapproved drug developed by Gilead Sciences Inc. of the United States to treat Ebola. To win approval as a drug for the new coronavirus, the U.S. National Institutes of Health has been leading clinical trials whose participants include Japan’s National Center for Global Health and Medicine.
Gilead Sciences has also been conducting clinical tests on its own.
Of 53 patients who have been administered the drug, about 70 percent showed improvement in respiratory function, according to a team of researchers from Japan, the United States, Europe and elsewhere.
Remdesivir is expected to be approved in Germany and the United States in the near future. When an application is filed in Japan, the government will begin procedures for the special approval system, according to sources. The drug is expected to be approved in Japan after opinions are heard at a relevant council at the Health, Labor and Welfare Ministry.
The special approval system is intended to shorten the screening period for a drug, which usually takes about a year. To apply the system, the drug in question must be urgently needed due to an epidemic of a disease that could severely affect the lives and health of the people.
Applying the system also requires the drug to have been approved in a foreign country whose screening levels are on par with those of Japan.
Stocks of remdesivir are said to be almost empty at the moment, except for those reserved for clinical tests. However, “since Japan is contributing to the clinical trials, a certain amount of stock will be allotted to us,” a senior government official told The Yomiuri Shimbun. “We can purchase the drug from the United States.”
The government is also considering allowing the use of Avigan an anti-flu drug that is currently administered mainly in clinical trials for patients with mild symptoms from the new coronavirus.
Avigan “has been administered in more than 2,000 cases, and we have received reports that it is effective in improving symptoms,” Abe said at Monday’s lower house plenary session. “We are working hard to approve the drug as early as possible.”
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