Japan is now only the second country in the world after the United States to approve the use of the antiviral drug, remdesivir, as a treatment for COVID-19. Remdesivir will be sole in Japan under the brand name, "Veklury."
Japan's Ministry of Health, Labour and Welfare granted regulatory approval of Veklury (remdesivir) as a treatment for SARS-CoV-2 infection in critically ill patients under an exceptional approval pathway. It referenced the Emergency Use Authorization (EUA) for remdesivir in the United States issued by the federal government last May 1.
"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 Dr 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."
Dr Parsey said the approval is based on clinical data from the U.S. National Institute of Allergy and Infectious Diseases' (NIAID) global Phase 3 trial, Gilead's Phase 3 SIMPLE trial in patients with severe manifestations of COVID-19, and available data from Gilead's compassionate use program, including patients in Japan. Remdesivir is administered intravenously.
On May 1, the U.S. Food and Drg Administration (FDA)issued an EUA remdesivir, which is still in human clinical trials. It limited its authorization to the emergency use of remdesivir in hospitalized adults and children with suspected or laboratory-confirmed COVID-19 and severe disease.
The EUA will facilitate broader use of remdesivir to treat hospitalized patients with severe COVID-19 disease. It will also allow access to remdesivir at additional hospitals across the U.S.
The FDA said the benefits of remdesivir outweigh its risks. FDA chief scientist Dr Denise Hinton said there is "no adequate, approved, and available alternative to the emergency use of remdesivir for the treatment of COVID-19." The FDA will control the use of remdesivir to ensure the use of the drug with the terms and conditions of the authorization.
"This EUA opens the way for us to provide emergency use of remdesivir to more patients with severe symptoms of COVID-19," said Daniel O'Day, Chairman and Chief Executive Officer of Gilead Sciences.
In the United States, remdesivir is an investigational drug that hasn't been approved by the FDA for any use. The safety and efficacy of remdesivir for the treatment of COVID-19 has not been established.
Remdesivir is an investigational nucleotide analog with broad-spectrum antiviral activity both in vitro and in vivo in animal models against multiple emerging viral pathogens, including Ebola, Marburg, MERS and SARS. In vitro testing by Gilead has demonstrated remdesivir is active against SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), the virus that causes COVID-19.
