Roche announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Ronapreve™(casirivimab and imdevimab), for the treatment of patients with 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 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. In these exceptional times, Roche stands together with society, governments, healthcare providers and all those working to overcome the pandemic. About the Japanese Special Approval for Emergency: Under article 14-3, Paragraph 1 of the Japanese Act on Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices, the Minister of Health, Labour and Welfare may approve a certain medical product that meets the following criteria, upon discussion with the Pharmaceutical Affairs and Food Sanitation Council: An emergency situation requires an unapproved medical product to be used to prevent damage to public health caused by the spread of diseases, and such emergency cannot be managed appropriately by any means other than the use of the unapproved product; Such product is legally available in a country with a regulatory system for medical products that is equivalent to Japan.