Trials & Filings

Japan First to Approve Roche’s Ronapreve to Treat COVID-19

Full approval is based on a global phase III trial which found casirivimab and imdevimab reduced hospitalization or death by 70%.

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By: Kristin Brooks

Managing Editor, Contract Pharma

Roche received approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for Ronapreve (casirivimab and imdevimab), for the treatment of mild to moderate COVID-19 via intravenous infusion. The antibody combination was granted a Special Approval Pathway under article 14-3 of the Pharmaceuticals and Medical Devices Act.    The approval is based on results from the global phase III REGN-COV 2067 study in high-risk non-hospitalized patients with COVID-19, which showed that casirivimab an...

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