Casirivimab and Imdevimab Approved in Japan for the Treatment of Mild-to-Moderate COVID-19
Japan’s Ministry of Health, Labour and Welfare (MHLW) has fully approved the combination of casirivimab and imdevimab to treat patients with mild-to-moderate COVID-19. This marks the first time a monoclonal-antibody cocktail has received full approval to treat COVID-19. This combination therapy is currently authorized for emergency use in more than 20 countries, including the United States, European Union, India, Switzerland, and Canada. The monoclonal antibody cocktail was approved in Japan after results from a phase 3 trial showed a 70% reduction in the risk of hospitalization or death in high-risk non-hospitalized patients who received casirivimab and imdevimab. The MHLW also reviewed results from a phase 1 trial that analyzed the safety, tolerability, and pharmacokinetics of the combination therapy in Japanese subjects. Multiple analyses have shown that casirivimab and imdevimab retain potency against circulating variants of concern, including Delta (B.1.162.2, first seen in India), Gamma (P.1, first seen in Brazil), and Beta (B.1.351, first seen in South Africa).