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
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