“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.”
Japan becomes first country to approve Ronapreve (casirivimab and imdevimab) for the treatment of mild to moderate COVID-19 in adults and paediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19 and/or hospitalisation. The US EUA is temporary and does not take the place of the formal biologics license application (BLA) submission, review and approval process.
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