Gilead's Remdesvir (Veklury®) Received The World's First Approval In Japan!

- May 18, 2020-

The world is eagerly awaiting the emergence of special-effect medicines, among which the anti-viral drugs of Gilead Sciences-"People's Hope" remdesvir are the most popular. Any clues about the medicine always affect the public's tight nerves.


On the evening of April 29, data from two phase III clinical trials showed that ridcivevir was effective in treating patients with COVID-19. Based on the results, the US FDA issued an Emergency Use Authorization (EUA) in early May to use remdesvir for the treatment of severe COVID-19 hospitalized patients. Gilead has pledged to donate a total of 1.5 million doses of remdesvir free of charge. These drugs are currently being scheduled and distributed by the US government to maximize the treatment of patients in major hospitals in the United States who urgently need emergency treatment.


A few days before the publication of the above two Phase III clinical data, Japanese Prime Minister Shinzo Abe has shouted Gilead: As long as the application is submitted, Redisive will be approved immediately! Never thought that happiness came so fast!


On May 7, Gilead announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved special approval channels to approve Veklury (remdesivir) as a treatment drug for new coronavirus (SARS-CoV-2) infection. The virus that causes the new coronavirus pneumonia. The special approval grant was attributed to the pandemic of the new coronavirus pneumonia, which refers to the emergency use authorization (EUA) of remdesvir in the United States.


This approval is based on: (1) data from a placebo-controlled global phase III clinical trial conducted by the National Institute of Allergy and Infectious Diseases (NIAID) in the treatment of patients with moderate to severe symptoms of COVID-19 (including critically ill patients); ) The data of an open-label global phase III trial carried out by Gilead for the treatment of severe COVID-19 patients; (3) the existing data of the Gilead sympathetic medication program (including Japanese patients).


Gird Science Chief Medical Officer Merdad Parsey, MD, said: “Japan ’s approval of remdesivir is based on the urgent need to treat critically ill patients in Japan. This reflects the special situation of this pandemic. We thank the Japanese Ministry of Health, Labor and Welfare for working Leadership and cooperation in responding to this public health emergency. "


Due to the current public health emergency, the US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for remdesvir to treat new coronavirus pneumonia. In the United States, remdesvir is a drug under study and has not yet been approved by the FDA for any use. Its safety and effectiveness for the treatment of new coronavirus pneumonia have not been determined. In the United States, remdesvir is only authorized to treat severely hospitalized patients with new coronavirus pneumonia. Please see below for other important information about the authorized use of remdesvir in the United States.


remdesvir has not obtained permission or approval in countries other than Japan, and ongoing clinical trials continue to evaluate its safety and effectiveness. Gilead continues to work with global regulatory agencies to ensure the availability of appropriate ridxivir.


About remdesvir:


remdesvir is a nucleotide analogue under study with broad-spectrum antiviral activity. It has shown effects on a variety of emerging viral pathogens in vitro and in vivo studies in animal models, including Ebola virus and Marl virus. Fort virus, Middle East respiratory syndrome (MERS) and atypical pneumonia (SARS) viruses. An in vitro test conducted by Gilead showed that remdesvir is active against SARS-CoV-2. Several ongoing phase III clinical trials are evaluating the safety and effectiveness of remdesvir in the treatment of novel coronavirus pneumonia.


Important information about remdesvir in the United States


remdesvir (GS-5734 ™) received an emergency use authorization for the treatment of suspected or laboratory-confirmed SARS-CoV-2 infection and severe new coronavirus pneumonia. SARS-CoV-2 is a coronavirus that causes a new coronavirus pneumonia disease. Severe disease is defined as the patient's oxygen saturation (SpO2) ≤ 94% under indoor air conditions, or the need for oxygen support, or the need for mechanical ventilation, or the need for extracorporeal pulmonary membrane oxygenation (ECMO). remdesvir must be administered intravenously, which is approved for adult or pediatric patients who have been admitted to the hospital and can receive clinical intravenous injections.


remdesvir is a drug under study and has not been approved by the FDA. The safety and effectiveness of remdesvir in the treatment of new coronavirus pneumonia are not yet clear. remdesvir is only authorized to prove the establishment of the emergency use authorization during the declaration period, unless the authorization is suspended or revoked earlier.