Pooled Phase 3 data for anemia of CKD patients, incident dialysis or not receiving dialysis from the ALPINE Phase 3 clinical trial program

TOKYO, May 19, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced results from a pooled analysis of patients with symptomatic anemia associated with chronic kidney disease (CKD) who are non-dialysis-dependent (NDD) and incident dialysis-dependent (IDD) from four Phase 3 studies evaluating the safety and efficacy of EVRENZO™ (roxadustat). These data presented during a mini-oral session at the 59th European Renal Association (ERA) Congress, taking place between May 19–22, 2022, showed no evidence of an increased risk of cardiovascular events or mortality with roxadustat compared with standard of care, erythropoiesis-stimulating agents (ESAs).

Roxadustat was non-inferior to ESA for risk of a major adverse cardiovascular event (MACE) (95% confidence interval [CI]: 0.61, 1.02) and a major adverse cardiovascular event plus congestive heart failure or unstable angina requiring hospitalization (MACE+) (95% CI: 0.62, 0.98) with a consistent finding for all-cause mortality (ACM) (95% CI: 0.57, 1.05). Hazard ratios for MACE, MACE+ and ACM vs ESA were 0.79, 0.78 and 0.78, respectively, favoring roxadustat. Although treatment-emergent adverse events occurred commonly in both the roxadustat and ESA groups, patients rarely discontinued either study drug because of an adverse event.

“I’ve seen first-hand the effect anemia can have on those living with CKD, and it impacts almost every aspect of their daily lives,” said Professor Jonathan Barratt, Ph.D., FRCP, Consultant Nephrologist at the University of Leicester, United Kingdom. “I’m pleased to present these data which demonstrate that, as an alternative oral treatment that controls anemia with a reduced need for IV iron compared to standard of care, roxadustat has the potential to alleviate the burden many living with this condition have – with no risk of increase in cardiovascular events or mortality when compared with the existing standard of care.”

As a first-in-class orally administered inhibitor of hypoxia-inducible factor prolyl hydroxylase (HIF-PH), roxadustat increases hemoglobin levels with a mechanism of action that is different from that of ESAs. Roxadustat activates the body’s natural protective response to reduced oxygen levels in the blood. This response involves the regulation of multiple, complementary processes that promote a coordinated erythropoietic response and increase the blood’s oxygen-carrying capacity.

“Astellas is dedicated to addressing unmet medical needs and providing innovative solutions in nephrology,” said Ahsan Arozullah, Senior Vice President and Head of Development Therapeutic Areas, Astellas. “These data presented today add to the extensive clinical evidence available for roxadustat and provide further assurance to the nephrology community of the positive impact roxadustat can have for patients with symptomatic anemia associated with CKD.”

Additional Astellas mini-oral presentations at the 59th ERA Congress 2022 include:

Title: 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 (Abstract 2379)

Presenter: Jonathan Barratt, University of Leicester, United Kingdom

Title: 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 (Abstract 1008)

Presenter: Luca De Nicola, University of Campania, Naples, Italy

 

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