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Akebia Announces Swissmedic Approval of Vafseo® (vadadustat)
CAMBRIDGE, Mass., June 20, 2023 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA) today announced that the Swiss Agency for Therapeutic Products
About this update from Akebia Therapeutics, Inc.
[{"type":"text","content":"CAMBRIDGE, Mass., June 20, 2023 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA) today announced that the Swiss Agency for Therapeutic Products (Swissmedic) has granted marketing authorization for 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.\n\n \n \n \n \n \n \n\n \n\"With Swissmedic marketing authorization of Vafseo, we're pleased to note that vadadustat is now approved in 34 countries,\" said John P. Butler, Chief Executive Officer of Akebia. \"We anticipate our partner Medice will launch Vafseo in Europe this year, and we are eager to support the launch to bring an additional therapeutic option to patients on dialysis.\"\nAnemia due to CKD, common among patients on dialysis, is often associated with adverse clinical outcomes. Throughout Europe, it is estimated that at least 325,000 dialysis patients are currently treated for anemia associated with CKD.\nThe Swissmedic 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).\nIn 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.\nAbout VadadustatVadadustat 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 product...