Approval of vadadustat as Vafseo in Japan for the treatment of anemia due to chronic kidney disease.- Mitsubishi Tanabe + Akebia

Akebia Therapeutics, Inc.announced the first regulatory approval of vadadustat, its oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the treatment of anemia due to chronic kidney disease (CKD). Mitsubishi Tanabe Pharma Corporation (MTPC), Akebia’s collaboration partner in Japan for vadadustat, has obtained manufacturing and marketing approval of vadadustat 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 on June 29, 2020

Vadadustat will be marketed by MTPC in Japan under the trade name Vafseo. 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. Injectable erythropoiesis-stimulating agents (ESAs) are currently the standard of care. Vadadustat provides adult patients with a convenient, once-daily oral therapeutic for the treatment of anemia due to CKD in Japan.

,