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Astellas and FibroGen's Evrenzo (roxadustat) Receive EC's Approval for Symptomatic Anemia Associated with Chronic Kidney Disease

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Astellas and FibroGen's Evrenzo (roxadustat) Receive EC's Approval for Symptomatic Anemia Associated with Chronic Kidney Disease

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  • The approval is based on the P-III program including 8 studies evaluating Evrenzo in 9600 patients with symptomatic anemia associated with CKD- regardless of dialysis status & prior ESA treatment. Following the EC's approval- FibroGen to receive $120M milestones along with royalties based upon EU sales
  • The results demonstrated that the therapy was effective in maintaining target Hb levels & safety profile is reflective for CKD populations compared to ESAs
  • Roxadustat is a HIF-PH inhibitor & is approved in EU member states- including the EEA countries- Japan- China- Chile & South Korea for the same indication in adult patients on DD & NDD

  | Ref: Astellas | Image:Astellas

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