Japan approved the Gilead Sciences antiviral drug remdesivir Thursday for treatment of severe COVID-19 patients, under an exceptional approval pathway based on clinical data from the U.S. National Institute of Allergy and Infectious Diseases’ phase three trial.
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted regulatory approval of Veklury® (remdesivir) as a treatment for SARS-CoV-2 infection, the virus that causes COVID-19, under an exceptional approval pathway. The exceptional approval was granted due to the COVID-19 pandemic and references the Emergency Use Authorization of remdesivir in the United States.
The approval is based on clinical data from the U.S. 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 Gilead’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, Labour and Welfare for their leadership and collaboration, as we together work to respond to this public health emergency.”
Remdesivir is not yet licensed or approved outside of Japan and ongoing clinical trials continue to evaluate its safety and efficacy. Gilead continues to work with global regulatory authorities to ensure appropriate access to remdesivir.
The approval references the United States’ Emergency Use Authorization of the drug to treat severe cases of COVID-19.
Japan and the United States are the only countries to authorize use of remdesivir for treatment of COVID-19.
The NIAID trial suggested that remdesivir helped patients with serious breathing issues that require oxygen support to recover faster.
It remains unknown whether remdesivir is safe and effective for the treatment of COVID-19, says Gilead in the announcement.
On Sunday, Gilead’s CEO announced the company would donate its entire remdesivir stockpile to the U.S. government, so it is unclear how quickly the company will be able to manufacture sufficient quantities of the drug to meet Japan’s needs (a company spokesperson did not respond to this question by time of publication).