Akebia Announces Approval of Vafseo® (vadadustat) in Australia and Provides Commercial Update

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[{"type":"text","content":"CAMBRIDGE, Mass., Sept. 26, 2023 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA) today announced that Australia's Therapeutic Goods Administration (TGA) has granted approval for Vafseo® (vadadustat), an oral hypoxia-inducible factor prolyl hydroxylase inhibitor for the treatment of anemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis.\n\n \n \n \n \n \n \n\n \nThe TGA approval for 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).\nVadadustat 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.\n\"The Akebia team continues to execute on our plan to make Vafseo available to patients globally,\" said John Butler, Chief Executive Officer of Akebia. \"With authorization in Australia, the product is now approved in 35 countries. We also expect to resubmit our new drug application for vadadustat in the U.S. by the end of this quarter.\"\nTo support the global launch of Vafseo and prepare for a potential launch in the U.S., Akebia also announced an addition to its commercial team. Akebia appointed Graham Ray as Vice President, Key Accounts, reporting to Bennett Smith, Senior Vice President, Commercial, to lead customer engagement. Mr. Ray has a track record of successful product launches, brand growth and sales operations efficiencies, expertise he gained over nearly 20 years at Takeda Pharmaceuticals. Mr. Ray will be responsible for leading the sales efforts to launch vadadustat in the U.S., if approved, as well as work to maximize the value of Auryxia® (ferric citrate).\nAkebia slightly lowered Auryxia net ...

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