Just days after Foster City, Calif.-based Gilead Sciences Inc. gained emergency use authorization (EUA) from the FDA for antiviral Veklury (remdesivir) for the treatment of patients with SARS-CoV-2 infection, the virus that causes COVID-19, Japan invoked its own exceptional approval pathway to give the drug the green light to treat patients with severe COVID-19.

The Japanese Ministry of Health, Labour and Welfare based its decision on clinical data from the U.S. National Institute of Allergy and Infectious Diseases’ placebo-controlled phase III study in patients with moderate to severe symptoms of COVID-19, including those who were critically ill, and Gilead’s phase III SIMPLE study, evaluating both the shorter and longer-duration treatment approaches, and available data from the company’s compassionate use program, including patients in Japan.

Gilead said it is working with global authorities on patient access to remdesivir.

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