Veklury (remdesivir) has been approved in Japan as a treatment for COVID-19 under an exceptional approval pathway, Gilead has announced.
The exceptional approval was granted in the wake of the COVID-19 pandemic and references the Emergency Use Authorisation of remdesivir in the United States.
The approval is 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 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, Chief Medical Officer at Gilead Sciences.
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.