Tuesday, June 20, 2023
Akebia Therapeutics, Inc. (Nasdaq: AKBA) has announced that Vafseo® (vadadustat), an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, has received marketing authorization from the Swiss Agency for Therapeutic Products (Swissmedic). The approval allows Vafseo to be used for the treatment of symptomatic anemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis.
Akebia's Chief Executive Officer, John P. Butler, expressed satisfaction with the Swissmedic approval, noting that Vafseo is now approved in 34 countries. He mentioned that their partner Medice is expected to launch Vafseo in Europe this year, providing an additional therapeutic option for dialysis patients.
Anemia is a common complication among CKD patients on dialysis and is linked to adverse clinical outcomes. It is estimated that over 325,000 dialysis patients in Europe are currently being treated for anemia associated with CKD.
Swissmedic's approval of Vafseo is based on a comprehensive development program that included over 7,500 patients, including the global Phase 3 clinical program known as INNO2VATE, which evaluated vadadustat's effectiveness in treating anemia due to CKD in adult dialysis patients.
In the INNO2VATE studies, vadadustat demonstrated non-inferiority to darbepoetin alfa, meeting the primary and key secondary efficacy endpoints. These endpoints were measured by the mean change in hemoglobin (Hb) levels between baseline and the primary evaluation period (weeks 24 to 36) and secondary evaluation period (weeks 40 to 52). Vadadustat also met the primary safety endpoint, showing non-inferiority to darbepoetin alfa in terms of time to the first occurrence of major adverse cardiovascular events, which included all-cause mortality, non-fatal myocardial infarction, or non-fatal stroke across both INNO2VATE studies.
Vafseo is an oral HIF-PH inhibitor designed to simulate the physiological response of the body to altitude, where lower oxygen availability leads to the stabilization of hypoxia-inducible factor, resulting in increased production of red blood cells and improved oxygen delivery to tissues. It's important to note that Vadadustat has not yet been approved by the U.S. Food and Drug Administration (FDA).