Business
Akebia Reports Third Quarter 2020 Financial Results and Recent Business Updates
- Presented positive global Phase 3 data for vadadustat from the INNO2VATE program for the treatment of anemia due to chronic kidney disease in adult patients
About this update from Akebia Therapeutics, Inc.
[{"type":"text","content":"- Presented positive global Phase 3 data for vadadustat from the INNO2VATE program for the treatment of anemia due to chronic kidney disease in adult patients on dialysis at ASN Kidney Week\n - Completed pre-NDA meeting with the FDA and remain on track to submit vadadustat NDA\n - Conference call today at 9:00 a.m. ET\n\n\nCAMBRIDGE, Mass., Nov. 5, 2020 /PRNewswire/ -- Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose of bettering the lives of people impacted by kidney disease, today reported financial results for the third quarter ended September 30, 2020 and provided business updates, including confirming completion of a pre-NDA meeting with the U.S. Food and Drug Administration (FDA) for vadadustat. Vadadustat is Akebia's investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) in development for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis and not on dialysis. \n\n \n \n \n \n \n \n\n \n\"We recently completed our pre-NDA meeting with the FDA. This was an important milestone for our vadadustat development program, and we remain on track to submit an NDA to the FDA as early as possible next year. A key component of this NDA is the positive data from our global Phase 3 INNO2VATE program for the treatment of anemia due to CKD in adult patients on dialysis, which we shared most recently at ASN Kidney Week. These data were clear and consistent, and showed that vadadustat achieved both the primary and key secondary efficacy endpoints, as well as the primary and key secondary safety endpoints of the program for patients on dialysis. Based on our pre-NDA meeting, we remain confident that these results support the potential approval of vadadustat for the treatment of anemia due to CKD in adult patients on dialysis,\" said John P. Butler, President and Chief Executive Officer of Akebia Therapeutics. \"Subject to regulatory review and approval, we believe vadadustat has the potential to be a new oral standard of care to help address the unmet needs of adult patients on dialysis, including both incident and prevalent dialysis patients. We believe this could translate into a potential $2 billion market opportunity in the U.S., alone. Together with our collaborator, Otsuka, we look forward to bringing this innovative therapy to pa...