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

 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

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

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

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Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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