Gilead’s Veklury (remdesivir) approved by Japan’s MHLW for COVID-19
Gilead has announced that the Japanese Ministry of Health, Labor and Welfare approved Veklury (remdesivir) for severe COVID-19. The drug approved under an exceptional approval pathway, which was granted based on the Emergency Use Authorization of remdesivir in the United States.
The approval is based on the Phase 3 SIMPLE clinical trial; data is available under the compassionate use program. “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, Gilead Sciences.
Earlier the drug has received an Emergency Use Authorization from the Food and Drug Administration in the United States. The drug is only indicated for severe patients (patients with oxygen saturation (SpO2) <94% on room air or requiring supplemental oxygen or requiring ventilation or requiring extracorporeal membrane oxygenation (ECMO)).
The drug is indicated for both adults and pediatrics and is administered intravenously. The drug has not yet received approval from the US FDA for treating patients with COVID-19.