Health and Healthcare

Gilead Sciences Gains Remdesivir Approval in Japan

Chris Lange

Published: May 8, 2020 11:32 am

Gilead Sciences Inc. (NASDAQ: GILD) took another big step forward in its treatment for COVID-19 on Friday when a Japanese regulatory body approved that treatment.

Specifically, the Japanese Ministry of Health, Labour and Welfare has granted regulatory approval of Veklury (remdesivir) as a treatment for infection by SARS-CoV-2, the virus that causes COVID-19, under an exceptional approval pathway.

This exceptional approval was granted due to the COVID-19 pandemic and references the Emergency Use Authorization (EUA) of remdesivir in the United States. Due to the current public health emergency, the U.S. Food and Drug Administration (FDA) issued the EUA for remdesivir for the treatment of COVID-19.

Also, the Japanese approval was 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.

Merdad Parsey, MD, Ph.D., chief medical officer of Gilead Sciences, commented:

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. 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.

Gilead stock traded at $77.51 on Frida, in a 52-week range of $60.89 to $85.97. The consensus price target is $80.39.

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