Japanese nod to Ronapreve (casirivimab and imdevimab) for treatment of mild to moderate Covid-19

The MHLW based the approval on results from the global phase III REGN-COV 2067 study in high-risk non-hospitalised patients with COVID-19, which showed that casirivimab and imdevimab reduced hospitalisation 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 authorised for emergency use or temporary pandemic use in additional territories and regions, including in the European Union, United States, India, Switzerland and Canada. It is also undergoing rolling review by the European Medicines Agency and was granted a scientific opinion (under Article 5(3) of Regulation 726/2004) by the Committee for Medicinal Products for Human Use, 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 commercialisation rights in Japan from Roche, and is working with the Japanese government to ensure an appropriate and timely supply of Ronapreve.

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