• 27 Feb 2023
• Admin
• News Article

EMA committee recommends approval of Akebia Vafseo to treat symptomatic anaemia associated with CKD in adults on chronic maintenance dialysis

Akebia Therapeutics, Inc., a fully integrated biopharmaceutical company, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the European Commission (EC) to approve 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 EC will review the CHMP recommendation and deliver a final decision in approximately two months. The decision will be applicable to all 27 European Union member states plus Iceland, Norway and Liechtenstein. "We are extremely pleased by the CHMP's positive opinion for our marketing authorisation application for Vafseo for patients on dialysis," said John P. Butler, chief executive officer of Akebia. "We are driven to better the lives of people impacted by chronic kidney disease and a positive opinion is a critical step toward delivering on this purpose. We believe more treatment options are needed for patients with anaemia on dialysis, and if we receive a positive EC decision Vafseo could offer an oral treatment to help address this need. This is also an important milestone in our process to identify and secure a potential partner in Europe to bring Vafseo to those patients." The CHMP based its positive opinion 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. Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor designed to mimic the physiologic effect of altitude on oxygen availability. At higher altitudes, the body responds to lower oxygen availability with stabilization of hypoxia-inducible factor, which can lead to increased red blood cell production and improved oxygen delivery to tissues. Vadadustat is an investigational new drug and is not approved by the US Food and Drug Administration (FDA). On March 29, 2022, the FDA issued a complete response letter to Akebia's New Drug Application for vadadustat for the treatment of anaemia due to chronic kidney disease (CKD). Vadadustat is currently under review by the European Medicines Agency for the treatment of anaemia due to CKD in adults. In Japan, vadadustat is approved as a treatment for anaemia due to CKD in both dialysis-dependent and non-dialysis dependent adult patients. Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease.