Shots:

• 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