Roche/Regeneron's COVID-19 Neutralizing Antibody Therapy Ronapreve Receives First Global Approval in Japan

On July 20, 2021, Roche announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Ronapreve (casirivimab and imdevimab), an antibody therapy co-developed with Regeneron, for the treatment of patients with mild-to-moderate COVID-19 via intravenous infusion. Notably, this antibody combination was granted approval through an exceptional approval pathway.

This approval is based on the results of the global Phase 3 clinical trial REGN-COV 2067 in high-risk non-hospitalized patients with COVID-19, which demonstrated that Ronapreve antibody therapy reduces the risk of hospitalization or death by 70% and shortens the duration of symptoms by 4 days, as well as a Phase 1 clinical study evaluating its safety, tolerability, and pharmacokinetics.