Akebia Therapeutics has announced that the European Commission (EC) has granted marketing authorisation for Vafseo (vadadustat), an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor for the treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis. The approval is applicable to all 27 European Union member states plus Iceland, Norway and Liechtenstein. Vadadustat is now approved in 32 countries.
“We’re extremely pleased the EC has approved Vafseo, an important milestone for Akebia, but even more impactful for the hundreds of thousands of Europeans diagnosed with anaemia associated with CKD on dialysis,” said John P Butler, chief executive officer of Akebia. “We believe patients receiving chronic maintenance dialysis would benefit from additional therapeutic options. With approval, we’re eager to select a European partner who can quickly bring Vafseo to those patients.”
Anaemia associated with CKD, common in patients on dialysis, is a debilitating condition which may be associated with many adverse clinical outcomes. Vafseo, approved in 150mg, 300mg and 450mg film-coated tablets, provides a once-daily oral treatment option for dialysis dependent patients with symptomatic anaemia associated with CKD. Throughout Europe, more than 200,000 dialysis patients are currently treated for anaemia associated with CKD.
The approval follows the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) positive opinion issued in February 2023, recommending the EC approve Vafseo. The approval is based on data from a comprehensive development program that included over 7,500 patients, including the global Phase 3 clinical program of vadadustat for the treatment of anaemia due to CKD in adult patients on dialysis (INNO2VATE).
In the study of adult patients on dialysis, vadadustat achieved the primary and key secondary efficacy endpoint in each of the two INNO2VATE studies, demonstrating non-inferiority to darbepoetin alfa as measured by a mean change in haemoglobin between baseline and the primary evaluation period (weeks 24–36) and secondary evaluation period (weeks 40–52). Vadadustat also achieved the primary safety endpoint of the INNO2VATE program, defined as non-inferiority of vadadustat versus darbepoetin alfa in time to first occurrence of major adverse cardiovascular events, which is the composite of all-cause mortality, non-fatal myocardial infarction, or non-fatal stroke across both INNO2VATE studies.