Business
Akebia Announces Positive 52-week Efficacy and Safety Data for Vadadustat from Two Pivotal Phase 3 Studies in Japanese Patients with Anemia Due to Chronic Kidney Disease
Each Study Met Primary Endpoint at 24-Weeks and Showed Vadadustat’s Effect on Hemoglobin Was Sustained Through to 52-Weeks Data Presented at the American
About this update from Akebia Therapeutics, Inc.
[{"type":"text","content":"\n\nEach Study Met Primary Endpoint at 24-Weeks and Showed Vadadustat’s Effect on Hemoglobin Was Sustained Through to 52-Weeks\n\n\nData Presented at the American Society of Nephrology (ASN) Kidney Week 2019 by Mitsubishi Tanabe Pharma Corporation (MTPC)\n\n\n CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nAkebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company focused on the development and commercialization of therapeutics for people living with kidney disease, today announced that MTPC, Akebia’s development and commercialization collaboration partner in Japan for vadadustat, presented positive 24-week and 52-week data from two Phase 3 active-controlled pivotal studies evaluating the efficacy and safety of vadadustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), in Japanese patients with anemia due to chronic kidney disease (CKD), at ASN Kidney Week 2019. Each study met its primary endpoint based on mean hemoglobin level at weeks 20 and 24, and showed vadadustat’s effect on hemoglobin was sustained through to 52 weeks in each study.\n\n\nIn July, MTPC submitted a Japanese New Drug Application (JNDA) to the Ministry of Health, Labor and Welfare in Japan for marketing approval of vadadustat as a treatment for anemia due to CKD. The JNDA is the first regulatory submission for marketing approval of vadadustat and, if approved, is expected to lead to the first launch of vadadustat worldwide, next year. Details regarding these study results are provided below.\n\n\n“Correcting and maintaining hemoglobin levels within a target range is paramount in the treatment of anemia due to chronic kidney disease,” said John P. Butler, President and Chief Executive Officer of Akebia. “The 52-week data from MTPC’s studies reinforce our belief in vadadustat’s potential to make a difference in the lives of people impacted by anemia due to CKD.”\n\n\nTop-Line Results from Pivotal Phase 3 Study in Non-Dialysis Dependent CKD Subjects (J01 Study) \n\n\nMTPC’s phase 3 randomized, open-label, active-controlled correction and conversion study assessed the efficacy and safety of vadadustat compared to darbepoetin alfa, an erythropoiesis stimulating agent (ESA), in 304 Japanese non-dialysis dependent subjects with anemia due to CKD, with a treatment duration of 52 weeks. Data from the planned analysis at 24 we...