Japan authorises exceptional approval of Gilead’s remdesivir for severe COVID-19

pharmafile | May 12, 2020 | News story | Manufacturing and Production, Sales and Marketing COVID-19, Gilead, Japan, coronavirus, pharma, remdesivir 

Remdesivir, perhaps the leading hope in the race against COVID-19, has secured approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) under the brand name Veklury for the treatment of severe COVID-19, its license holder Gilead has announced.

The antiviral therapy has emerged as the most effective treatment available thus far against the virus amongst a dearth of alternatives, though the mostly-positive efficacy data accumulated so far has been the subject  of criticism due to small study sizes which have often lacked control arms or have not been peer-reviewed.

The approval was made under an “exceptional approval pathway” in light of the ongoing public health threat posed by the SARS-CoV-2 pandemic, and the drug application referenced that the US FDA had already taken similar action with its emergency approval of the drug in early May.

Further supporting the application was Phase 3 data drawn from the US National Institute of Allergy and Infectious Diseases (NIAID)’s global study of the drug in patients hospitalised with severe COVID-19, as well as data drawn from Gilead’s own compassionate use programme.

“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,” commented Dr Merdad Parsey, Chief Medical Officer at Gilead. “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.”

However, Gilead was also keen to point out that “remdesivir is an investigational drug that has not been approved by the FDA for any use, and the safety and efficacy of remdesivir for the treatment of COVID-19 has not been established. The distribution of remdesivir in the United States has been authorised only for the treatment of hospitalised patients with severe COVID-19.”

Matt Fellows

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