Swiss pharma giant Roche (ROG: SIX) today announced that Japan’s Ministry of Health Labor and Welfare (MHLW) has approved Ronapreve (casirivimab and imdevimab), for the indication of SARS-CoV-2 infection in patients with mild to moderate COVID-19 via intravenous infusion.
The antibody combination, formerly known as REGN-COV2, was developed in cooperation with US biotech Regeneron (Nasdaq: REGN), and was granted a Special Approval Pathway under article 14-3 of the Pharmaceuticals and Medical Devices Act. This makes Japan the first country to formally authorize the drug.
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