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Akebia Therapeutics Announces First Commercial Launch of VAFSEO™ (vadadustat tablets), a New Oral Treatment for Anemia Due to Chronic Kidney Disease, in Japan
VAFSEO Launch Marks Availability of Convenient Once-Daily Oral Treatment for Adult Patients on Dialysis and Not on Dialysis in Japan CAMBRIDGE, Mass., Aug.
About this update from Akebia Therapeutics, Inc.
[{"type":"text","content":"VAFSEO Launch Marks Availability of Convenient Once-Daily Oral Treatment for Adult Patients on Dialysis and Not on Dialysis in Japan\n\n\n CAMBRIDGE, Mass., Aug. 26, 2020 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that vadadustat, its oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), is now commercially available in Japan as a treatment for anemia due to chronic kidney disease (CKD) under the trade name VAFSEO™. VAFSEO has been included in the Japan National Health Insurance drug price listing and was granted regulatory approval as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis dependent adult patients by the Ministry of Health, Labour and Welfare in Japan in June 2020. The starting dose for VAFSEO is indicated at 300 mg with a maximum dose indicated at 600 mg.\n\n \n \n \n \n \n \n\n \nVAFSEO provides adult patients in Japan with a once-daily treatment option and has the potential to set a new oral standard of care for the treatment of renal anemia in Japan. An estimated 13 million people in Japan have advanced stages of CKD. Anemia is common in patients with CKD, and its prevalence increases as CKD progresses. Anemia due to CKD can result in serious complications including irregular or unusually fast heartbeat, enlargement of the heart, and heart failure and also has well-documented impacts on quality of life. Injectable erythropoiesis-stimulating agents (ESAs) are currently the standard of care. \nIn 2015, Akebia and Mitsubishi Tanabe Pharma Corporation (MTPC) entered into a collaboration agreement that provided MTPC with exclusive rights to develop and commercialize vadadustat in Japan and certain other Asian countries. Under the terms of the agreement, Akebia is eligible to receive up to approximately $190 million in future milestone payments from MTPC, based upon achievement of certain regulatory and sales milestones. MTPC is also obligated to make tiered double-digit royalty payments to Akebia of up to 20% on sales of vadadustat in Japan and certain other Asian countries, subject to regulatory approval.\nVadadustat is in global Phase 3 development for the treatment of anemia due to CKD and is not yet approved outside of Japan.\nAbout Vadad...