Three abstracts provide additional insights into roxadustat safety profile and effect on iron parameters 

TOKYO, May 16, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) announced the presentation of new roxadustat data at the 59th European Renal Association (ERA) Congress, taking place May 19–22, 2022. 

Two presentations focus on pooled analyses from the comprehensive ALPINE Phase 3 clinical trial program, reinforcing the overall safety profile of roxadustat with further details on cardiovascular safety. Both compare roxadustat with current standard of care, erythropoietin-stimulating agents (ESAs), for patients with symptomatic anemia associated with chronic kidney disease (CKD) not receiving dialysis or just starting dialysis (incident dialysis). An evaluation of iron metabolism parameters and its clinical implications in patients with anemia of CKD in a similar population will also be presented.  

“At Astellas, we strive to improve outcomes for patients most in need of innovative new treatments,” said Ahsan Arozullah, Senior Vice President and Head of Development Therapeutic Areas, Astellas. “The clinical research being presented at the ERA Congress further validates the safety and efficacy profile of roxadustat as a new treatment option for those living with anemia of CKD and demonstrates Astellas’ continued commitment to this community of patients.” 
 

Mini-Oral Presentations 

Presentations and abstracts are available online starting Thursday, May 19, 2022, at 8:00 a.m. CEST, when all prerecorded presentations are published on the congress platform.

Presentation Title Lead Author Presentation Details 
Safety of Roxadustat Versus Erythropoiesis-Stimulating Agents for Treatment of 
Anemia in Patients With Chronic Kidney Disease Incident to or Not Receiving Dialysis: 
Pooled Analysis of Four Phase 3 Studies
J. Barratt Type: Mini-oral presentation
Abstract 631
Cardiovascular Safety of Roxadustat Versus Erythropoiesis-Stimulating Agents for Treatment of Anemia in Patients With Chronic Kidney Disease Incident to or Not Receiving Dialysis: Pooled Subgroup Analysis of Four Phase 3 Studies J. Barratt Type: Mini-oral presentation
Abstract 2379
Iron Parameters in Patients Treated With Roxadustat for Anemia Associated With Chronic Kidney Disease: Post Hoc Analysis of the Non-Dialysis-Dependent or Incident Dialysis Population From Four Phase 3 Studies. L. Nicola Type: Mini-oral presentation 
Abstract 1008


 

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