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Two products market ready?
A trusted leader in the renal community delivering unique products to people with kidney disease.
We are a fully integrated biopharmaceutical company. Our team works to address complications of kidney disease. We have both a commercially available medicine and a late stage oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), vadadustat, in global Phase 3 clinical development for the treatment of anemia due to CKD. Vadadustat and other HIF-PHIs are based on Nobel Prize-winning science.
Vadadustat is an investigational drug that has not been approved by the U.S. Food and Drug Administration (FDA) or any regulatory authority for use outside of Japan. Within Japan, Vadadustat, which completed its global Phase 3 program for the treatment of anemia due to CKD in both dialysis-dependent and non-dialysis dependent adult patients, and will be marketed by Mitsubishi Tanabe Pharma Corporation in Japan under the trade name VAFSEO™.
Vifor Pharma
In 2017, Akebia and Vifor Pharma (Vifor) entered into an agreement granting Vifor an exclusive license to sell vadadustat, if approved by the FDA and included in the Centers for Medicare & Medicaid (CMS) End Stage Renal Disease Prospective Payment System (ESRD PPS) bundle, to Fresenius Kidney Care Group, an affiliate of Fresenius Medical Care North America, for use solely within its dialysis facilities in the U.S. In 2019, we expanded this agreement so that the license would also be effective during the Transitional Drug Add-on Payment Adjustment (TDAPA) two-year period that is expected to precede the ESRD bundle period, and to provide Vifor with a license to sell vadadustat to certain third-party dialysis organizations in the U.S. as well. Akebia has retained all rights to commercialize vadadustat, in collaboration with Otsuka, for use in the non-dialysis dependent market and in other dialysis organizations, following FDA approval.
Japan - trials and partners...
A trusted leader in the renal community delivering unique products to people with kidney disease.
We are a fully integrated biopharmaceutical company. Our team works to address complications of kidney disease. We have both a commercially available medicine and a late stage oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), vadadustat, in global Phase 3 clinical development for the treatment of anemia due to CKD. Vadadustat and other HIF-PHIs are based on Nobel Prize-winning science.
Vadadustat is an investigational drug that has not been approved by the U.S. Food and Drug Administration (FDA) or any regulatory authority for use outside of Japan. Within Japan, Vadadustat, which completed its global Phase 3 program for the treatment of anemia due to CKD in both dialysis-dependent and non-dialysis dependent adult patients, and will be marketed by Mitsubishi Tanabe Pharma Corporation in Japan under the trade name VAFSEO™.
Otsuka Pharmaceutical Company
In 2016, Akebia entered into a collaboration and license agreement with Otsuka Pharmaceutical Company (Otsuka) for development and commercialization of vadadustat in the U.S. Under the terms of the agreement, the companies will contribute equally to commercialization efforts and share equally all costs and revenue in the U.S. In 2017, Akebia expanded its relationship with Otsuka to develop and commercialize vadadustat in Europe, China, Russia, Canada, Australia, the Middle East, and certain other territories. Akebia continues to lead the ongoing global Phase 3 development program for vadadustat.
Mitsubishi Tanabe Pharma Corporation
In 2015, Akebia entered into a collaboration agreement with Mitsubishi Tanabe Pharma Corporation (MTPC), providing MTPC with exclusive development and commercialization rights to vadadustat in Japan and certain other Asian countries. MTPC submitted a Japanese New Drug Application (JNDA) for vadadustat to the Ministry of Health, Labor and Welfare (MHLW) in Japan in July 2019, representing the first regulatory submission for vadadustat. On June 29, 2020, MTPC obtained approval of vadadustat as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis dependent adult patients. Vadadustat will be marketed by MTPC in Japan under the trade name VAFSEO™
$AKBA : 
We are a fully integrated biopharmaceutical company. Our team works to address complications of kidney disease. We have both a commercially available medicine and a late stage oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), vadadustat. Vadadustat and other HIF-PHIs are based on Nobel Prize-winning science.
VAFSEO® (vadadustat)is approved for use in 34 countries. Vadadustat has not been approved by the U.S. Food & Drug Administration.
