Astellas and FibroGen Report EMA’s Acceptance of MAA for Roxadustat to Treat Patients with Chronic Kidney Disease

Astellas and FibroGen Report EMA’s Acceptance of MAA for Roxadustat to Treat Patients with Chronic Kidney Disease

Shots:

  • The MAA is supported by P-III program which includes 9000+ patients globally and data from DOLOMITES study, results of which will be disclosed this year. Results of P-III program demonstrated that the therapy is efficacious in increasing & maintaining target hemoglobin levels with reduction in the use of IV iron in patients with CKD anemia, both DD & NDD
  • The data also supports favorable risk-benefit profile with CV and safety of roxadustat reflective of the underlying conditions of the CKD population. Additionally, FibroGen has submitted NDA to the US FDA based on the P-III program
  •  The EMA acceptance of roxadustat triggers a milestone of $130M by Astellas to FibroGen. Roxadustat is a first-in-class, hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), approved and launched to treat anemia associated with CKD in Japan in DD patients and in China in both DD and NDD patients

Click here to­ read full press release/ article | Ref: Astellas | Image: Astellas

Related News: Astellas and FibroGen’s Evrenzo (roxadustat) Receive MHLW’s Approval for Anemia Associated with Chronic Kidney Disease in Dialysis Patients