Mitsubishi Tanabe Pharma Launch of VAFSEO,for the treatment of renal anemia in Japan

Mitsubishi Tanabe Pharma Corporation announced that MTPC is launchingVAFSEO®Tablets 150mg and 300mg (VAFSEO®, vadadustat) which is anoralhypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor in-licensed from Akebia Therapeutics, Inc., forthe treatment ofrenal anemiaon August 26, 2020,in Japan following today’s inclusion ofVAFSEO®in the NHI drug price listing.

Renal anemia can present prior to dialysis and at any time during hemodialysisor peritoneal dialysis. Symptoms associated with anemia include fatigue, shortness of breath, insomnia, headache, and decreased energy, which may decrease a patient’s quality of life (QOL). It is reported that renal anemia develops from an early stage of chronic kidney disease (CKD)and its frequency increases as CKD progresses*.VAFSEO®would provide patients with a once-daily treatment option in Japan and has the potential to set a new oral standard of care for the treatment of renal anemiain both dialysis and non-dialysis patients in Japan.

MTPCand Fuso Pharmaceutical Industries Ltd. which has strength in the dialysis fieldconcluded a co-marketing agreement concerning VAFSEO®in Japan, in May2020. Through this collaboration, the two companies will be able toprovide appropriate information to more healthcare professionalsin Japan.MTPCwill provide a new and convenient, oral therapeutic medication for renal anemia patients in Japan by promoting the appropriate usage of VAFSEO®.*KohaguraK, et al. Prevalence of anemia according to stage of chronic kidney disease in a large screening cohort of Japanese. Clin Exp Nephrol.2009

About VAFSEO
VAFSEO in-licensed from Akebia Therapeutics, Inc., is an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor currently in global Phase 3 development for the treatment of anemia due to CKD. VAFSEO®is 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 production and improved oxygen delivery to tissues.VAFSEO®was obtained manufacturing and marketing approvalbythe Ministry of Health, Labour and Welfare in Japan on June 29, 2020