Astellas Reports Submission of sNDA to MHLW for Evrenzo (roxadustat) to Treat Anemia Associated with Chronic Kidney Disease in Non-Dialysis Dependent Patients in Japan

Shots:

• The sNDA is based on three studies in 500+ patients with NDD-CKD. The first P-III study involve assessing Evrenzo vs darbepoetin alfa resulted in meeting 1EPs of non-inferiority and maintenance of Hb levels over time and is well tolerated
• The other two studies (one P-II & one P-III) supported the safety and efficacy in patients naïve to erythropoiesis-stimulating agents (ESAs)
• Roxadustat is first-in-class, hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) and has received MHLW’s approval to treat anemia associated with DD-CKD in Sept’2019 and launched in Nov’19

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