Positive Results from the VOICE Study for Vafseo® in Dialysis Patients with CKD-Related Anaemia

Positive results from the VOICE study have been published for Vafseo® (vadadustat), a medicine from the MEDICE Health Family for the treatment of symptomatic anaemia associated with chronic kidney disease (CKD). Conducted by U.S. Renal Care (USRC) and Akebia Therapeutics, the study evaluated the safety and efficacy of administering Vafseo® three times weekly in patients with end-stage kidney disease receiving haemodialysis in dialysis centres.

A total of 2,116 patients participated in the study. Treatment with Vafseo® was compared with the previous standard of care based on erythropoiesis-stimulating agents (ESAs). The primary endpoint included all-cause mortality and hospitalisations, irrespective of cause.

The results of the planned interim analysis were unexpectedly positive: Vafseo® met the primary endpoint and demonstrated superiority over the previous standard therapy. This outcome was primarily driven by a statistically significant 10% reduction in the rate of hospitalisations. In light of these compelling findings, both the independent Data Monitoring Committee and the Steering Committee recommended the early termination of the study.

The new data from the VOICE study contribute to a deeper understanding of treatment options for CKD-related anaemia and further strengthen the clinical evidence supporting the use of Vafseo® in patients requiring dialysis.

Vafseo® has been approved in the United States since 2024 for the treatment of anaemia associated with chronic kidney disease in adults who have been receiving dialysis for at least three months (commercially available since January 2025). In the European Union, the medicine has been approved since 2024 for the treatment of symptomatic anaemia associated with chronic kidney disease in adults receiving chronic maintenance dialysis. The three-times-weekly dosing regimen investigated in the VOICE study is not currently included in either the US or EU marketing authorisation.

Prescribing information is available here: https://medice-health-family.com/de-de/fachportal/detail/vafseo

VAFSEO ® (vadadustat) is indicated for the treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Patients and healthcare professionals are asked to report any suspected adverse reaction via the national reporting system.

For UK: Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in Google Play Store or Apple Store. Adverse events should also be reported to MEDICE UK Ltd, 0204 582 2845, medicalinformation@medice.co.uk.

For EU: Adverse events should be reported to Medice Arzneimittel Pütter GmbH & Co. KG, +49 2371 9370, drugsafety@medice.de.

EU Healthcare Professionals are asked to report any suspected adverse reaction to their national authorities.