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

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 and imdevimab reduced hospitalization or death by 70% and symptom duration by four days, as well as a phase I clinical study, examining the safety, tolerability and pharmacokinetics in Japanese people.

Outside Japan, the antibody combination has been authorized for emergency use in additional territories and regions, including in the EU, U.S., India, Switzerland and Canada. It’s also undergoing rolling review by the EMA, supporting its use as a treatment option for patients with confirmed COVID-19 who do not require oxygen supplementation and who are at high risk of progressing to severe COVID-19.

In December 2020, Chugai obtained development and exclusive commercialization rights in Japan from Roche, and is working with the Japanese government to ensure an appropriate and timely supply of Ronapreve.

“Ronapreve has been shown to improve survival in high-risk, non-hospitalised COVID-19 patients by reducing the risk of hospitalisation and death. In addition, its ability to retain activity against emerging variants, including the Delta variant, has been demonstrated in preclinical studies,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Today’s approval brings hope to patients in Japan who can now access this important treatment option.”