42 abstracts featuring additional insights into roxadustat and anemia of chronic kidney disease to be presented

TOKYO, OCTOBER 19, 2020 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, PhD, “Astellas”) today announced that in collaboration with FibroGen and AstraZeneca, 42 roxadustat abstracts will be presented at the American Society of Nephrology (ASN) Kidney Week 2020 Reimagined congress. 

Six abstracts (one oral presentation and five ePosters) sponsored by Astellas focus on the use of roxadustat as a treatment in adult patients with anemia of chronic kidney disease (CKD). These abstracts include presentations of the Phase 3 DOLOMITES study (abstract #TH-OR02) and a Japanese Phase 3 CL-0310 study (#PO0269), with both studies evaluating roxadustat versus darbepoetin alfa as a treatment for patients with anemia of CKD not on dialysis. Other presentations include safety data from two Japanese Phase 3 studies assessing the ophthalmological effects of roxadustat treatment in patients with anemia of CKD on dialysis and not on dialysis, and a study of patients’ treatment preferences for anemia of CKD. 

“We are delighted by the breadth of roxadustat data being presented at ASN Kidney Week 2020,” said Salim Mujais, M.D., Senior Vice President and Global Therapeutic Area Head, Medical Specialties Development, Astellas. “It is encouraging that we continue to see the potential of roxadustat, a first-in-class hypoxia-inducible factor-prolyl hydroxylase inhibitor, for patients with anemia of CKD, and how its profile compares with existing treatment options.” 

FibroGen and AstraZeneca will present roxadustat data (nine oral presentations, including two late-breaking presentations, and 27 ePosters) predominantly focused on the efficacy and safety data from pooled analyses from several Phase 3 clinical studies of patients on dialysis and not on dialysis. Additional presentations evaluate data related to health care resource use, inflammation, iron homeostasis and safety event rates in patient populations with comorbid conditions like diabetes. 

Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in Japan, Europe, the Commonwealth of Independent States, the Middle East and South Africa. FibroGen and AstraZeneca are collaborating on the development and commercialization of roxadustat in the U.S., China, other markets in the Americas, Australia/New Zealand and Southeast Asia. Roxadustat is under regulatory review in Japan for the treatment of anemia in adult patients with CKD not on dialysis, and in the U.S. and EU in both patients on dialysis and not on dialysis. 

Astellas oral presentations:

Title: Roxadustat for the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis: A Phase 3, Randomized, Open-Label, Active-Controlled Study (#TH-OR02)
Presenter: Jonathan Barratt, University of Leicester, United Kingdom

  • Session date/time: Thursday, October 22, 2020 from 17:00-19:00 EDT

Astellas key presentations and ePosters will be available online starting Thursday, October 22, 10:00 a.m. EDT:

Title: A Phase 3, Multicenter, Randomized, Open-label, Active Comparator Conversion Study of Roxadustat in Non–Dialysis-Dependent (NDD) Patients with Anemia in CKD (#PO0269)

Title: Ophthalmological Effects of Roxadustat in the Treatment of Anemia in Dialysis-Dependent and Non–Dialysis-Dependent CKD Patients: Findings From Two Phase 3 Studies (#PO0267)

Title: Impact of Renal Impairment and Dialysis on the Pharmacokinetics and Pharmacodynamics of Roxadustat (#PO2369)

Title: Patient Preferences Study for Treatments of Anemia in CKD Patients Not on Dialysis (NDD) (#PO0289)

Title: A Marginal Structural Model to Estimate Causal Effect of Time-Dependent Anemia Status on Renal and Cardiovascular Outcomes Among Community-Dwelling Japanese Subjects at Beginning of Impaired Renal Function (#PO0270)

 

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