Roche Holding AG on Tuesday said that Japan has approved ronapreve for the treatment of patients with mild to moderate Covid-19.The Swiss pharmaceutical company said the approval is based on results from the global Phase 3 REGN-COV 2067 study, which found the antibody combination of casirivimab and imdevimab reduced hospitalization or death by 70% in high-risk, nonhospitalized patients.”Ronapreve has been shown to improve survival in high-risk, non-hospitalized Covid-19 patients by reducing the risk of hospitalization and death,” said Levi Garraway, Roche’s chief medical officer and head of global product development.
“In addition, its ability to retain activity against emerging variants, including the Delta variant, has been demonstrated in preclinical studies,” Mr. Garraway said.
Outside Japan, the antibody combination has been authorized for emergency use or temporary pandemic use in regions including in the European Union, the U.S., India, Switzerland and Canada.
It is currently undergoing rolling review by the European Medicines Agency.
Ronapreve is being jointly developed by Roche and Regeneron Pharmaceuticals Inc.
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