The United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Akebia Therapeutics’ Vafseo (vadadustat), an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor for the treatment of symptomatic anemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis.
“With the UK MHRA marketing authorization for Vafseo, we’re pleased to add another approval in Europe,” said John P. Butler, Chief Executive Officer of Akebia. “Again, I want to recognize our team, and the patients, physicians, investigators, and site coordinators who participated in our global trial and made this approval possible. We look forward to completing a partnership in Europe and bringing an additional therapeutic option to patients on dialysis in the United Kingdom.”
Anemia due to CKD, common among patients on dialysis, is often associated with adverse clinical outcomes. The MHRA approval of Vafseo 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 anemia 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 hemoglobin (Hb) between baseline and the primary evaluation period (weeks 24 to 36) and secondary evaluation period (weeks 40 to 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.