Therapy Areas: Cardiovascular
Astellas announces EVRENZO (roxadustat) Phase 3 clinical trial data
20 May 2022 -

Astellas Pharma Inc. (TSE: 4503) announced on Thursday results from a pooled analysis of patients with symptomatic anaemia 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).

The company said that these data, being presented during a mini-oral session at the 59th European Renal Association (ERA) Congress, taking place between 19-22 May 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 hospitalisation (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, favouring 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 anaemia 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 anaemia 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.'



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