Gilead’s Remdesivir Granted Regulatory Approval in Japan for Patients with Severe COVID-19

The Japanese Ministry of Health, Labour and Welfare (MHLW) has granted regulatory approval to Veklury (remdesivir) as treatment for SARS-CoV-2 infection under an exceptional approval pathway.

Gilead Sciences’ (Foster City, CA, USA) 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 conducted by Gilead has demonstrated that remdesivir is active against the virus that causes COVID-19. The safety and efficacy of remdesivir to treat COVID-19 are being evaluated in multiple ongoing Phase 3 clinical trials.

The exceptional approval of remdesivir in Japan was granted due to the COVID-19 pandemic and references the Emergency Use Authorization (EUA) of the investigational antiviral drug in the US. The approval was based on clinical data from the US National Institute of Allergy and Infectious Diseases’ global Phase 3 trial, Gilead’s Phase 3 SIMPLE trial in patients with severe manifestations of COVID-19, and available data from the company’s compassionate use program, including patients in Japan.

“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, Labor and Welfare for their leadership and collaboration, as we together work to respond to this public health emergency.”

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