Astellas Reports Results of Roxadustat in P-III DOLOMITES Study to Treat Anemia in Non-Dialysis Dependent Adult Patients with Chronic Kidney Disease

 Astellas Reports Results of Roxadustat in P-III DOLOMITES Study to Treat Anemia in Non-Dialysis Dependent Adult Patients with Chronic Kidney Disease

Astellas Signs a Three-Year Research Alliance with Harvard University Across Multiple Therapeutic Areas

Shots:

  • The P-III study involves assessing of Roxadustat (N=323) vs darbepoetin alfa (N=293) evaluating its safety and efficacy in (N=616) adult anemia patients with stage 3–5 chronic kidney disease (CKD)
  • The study meet its 1EPs & 2EPs also demonstrated superiority, showing correction of hemoglobin levels during the first 24 wks. (89.5% vs 78.0%), decrease in low-density lipoprotein cholesterol with LSM diff. (-0.403 mmol/L), non-inferiority data with mean arterial pressure with LSM diff. (-0.372 mmHg), safety & AEs (91.6% vs 92.5%), MACE (0.81 vs 0.90), Presented at ERA-EDTA 2020
  • Roxadustat (PO) is a novel inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase (PH) which leads to increment in hemoglobin levels, approved and launched for anemia associated with CKD in Japan in DD patients and in China for both DD and NDD patients

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Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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