Remdesivir, an antiviral drug found to have an effect on infections with the new coronavirus, will likely gain special approval in Japan after a Cabinet decision was made Saturday obtaining the approval of each minister in turn to revise a government ordinance.
The drug developed by U.S. pharmaceutical company Gilead Sciences, Inc. could be approved as soon as Thursday. This would make it the first commonly available drug in Japan for treating COVID-19, the disease caused by the new coronavirus.
The decision came in the wake of the U.S. Food and Drug Administration announcing Friday it would allow remdesivir, which has yet to be approved, to be used in severe infections with the new coronavirus. The U.S. granted a temporary permit under a system the FDA can use in emergencies for unapproved drugs, devices and other products when no other means are available.
Remdesivir is an antiviral that was developed to treat Ebola, a hemorrhagic fever caused by the Ebola virus. Clinical trials by the U.S. National Institutes of Health confirmed it has some effect on infections of the new coronavirus, such as shortening the recovery period of patients with pneumonia.
Japan's special approval based on a system under the Pharmaceuticals and Medical Devices Law that allows for an abbreviated domestic approval process in an emergency.
Once an application for approval is made, a Health, Labor and Welfare Ministry screening committee would convene quickly to give its views and move toward special approval.
Because Japan may only be able to secure a limited amount of the drug, the ministry is considering creating criteria for its administration, such as only to patients with severe symptoms who need ventilators. Remdesivir is administered intravenously in such cases.
The drug's side effects include inflammation of the liver, low blood pressure, nausea and tremors.
Read more from The Japan News at https://japannews.yomiuri.co.jp/
