Akebia Presents Results from its INNO2VATE Global Phase 3 Program; Demonstrated Efficacy and Cardiovascular Safety of Vadadustat for the Treatment of Anemia due to Chronic Kidney Disease in Adult Patients on Dialysis
Akebia Presents Results from its INNO2VATE Global Phase 3 Program; Demonstrated Efficacy and Cardiovascular Safety of Vadadustat for the Treatment of Anemia due to Chronic Kidney Disease in Adult Patients on Dialysis - INNO2VATE data presented at American Society of Nephrology Kidney Week 2020 Reimagined |
[22-October-2020] |
CAMBRIDGE, Mass., Oct. 22, 2020 /PRNewswire/ -- Akebia Therapeutics, Inc. (Nasdaq: AKBA) today announced the presentation of clinical data from its global INNO2VATE Phase 3 program, which demonstrated the efficacy and cardiovascular safety of vadadustat for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis, at American Society of Nephrology Kidney Week 2020 Reimagined (ASN Kidney Week). Vadadustat is Akebia's investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) in development for the treatment of anemia due to CKD. "The data presented today build on the positive top-line efficacy and safety results from INNO2VATE that were previously reported in May. More specifically, vadadustat's cardiovascular safety profile in dialysis patients is further reinforced by newly presented data clearly showing vadadustat achieved non-inferiority to darbepoetin alfa on MACE, expanded MACE, cardiovascular MACE, cardiovascular mortality, and all-cause mortality. These results were also consistent across multiple pre-specified populations," said Kai-Uwe Eckardt, M.D., Professor of Medicine and Head of the Department of Nephrology and Medical Intensive Care Medicine at the Charité in Berlin and Co-Chair of the independent Executive Steering Committee for INNO2VATE. "Left untreated, anemia in dialysis patients results in high transfusion requirements and severely reduces a patient's quality of life. The INNO2VATE results demonstrate that vadadustat could represent an attractive new oral treatment option for patients new to and already established on dialysis, upon approval." Results from INNO2VATE are being presented today at ASN Kidney Week during a presentation titled, "Global Phase 3 Clinical Trials of Vadadustat vs Darbepoetin Alfa for Treatment of Anemia in Patients with Dialysis-Dependent Chronic Kidney Disease" (Abstract TH-OR01). Highlights of the INNO2VATE ASN Kidney Week Presentation: Efficacy: - As previously reported, vadadustat achieved the primary and key secondary efficacy endpoints in each of the two INNO2VATE studies, which demonstrated non-inferiority to darbepoetin alfa as measured by a mean change in hemoglobin (Hb) between baseline and the primary evaluation period (weeks 24 to 36) and secondary evaluation period (weeks 40 to 52). Non-inferiority was achieved as the lower bound of the 95% confidence interval for the between-group difference of the mean Hb change did not fall below the pre-specified non-inferiority margin (-0.75 g/dL). Safety: - As previously reported, vadadustat achieved the primary safety endpoint of the INNO2VATE program, defined as non-inferiority of vadadustat versus darbepoetin alfa in time to first occurrence of a major adverse cardiovascular event (MACE), which is the composite of all-cause mortality, non-fatal myocardial infarction (MI), or non-fatal stroke across both INNO2VATE studies. - The incidence of treatment emergent adverse events during the incident dialysis patient (Correction/Conversion) study in vadadustat treated patients was 83.8% and 85.5% in darbepoetin alfa treated patients. During the study, the most common treatment emergent adverse events reported in vadadustat/darbepoetin alfa treated patients were hypertension (16.2%/ 12.9%) and diarrhea (10.1%/ 9.7%). Serious treatment emergent adverse events were lower in vadadustat treated patients at 49.7% compared to 56.5% for darbepoetin alfa treated patients. The incidence of treatment emergent adverse events during the prevalent dialysis patient (Conversion) study in the vadadustat treated patients was 88.3%, and 89.3% in darbepoetin alfa treated patients. During the study, the most common treatment emergent adverse events reported in vadadustat/darbepoetin alfa treated patients were diarrhea (13.0%/ 10.1%), pneumonia (11.0%/ 9.7%), hypertension (10.6%/ 13.8%), and hyperkalemia (9.0%/ 10.8%). Serious treatment emergent adverse events were slightly lower for vadadustat treated patients at 55.0% and 58.3% for darbepoetin alfa-treated patients. "We could not be more excited and pleased with such compelling results across our clinical development program in patients on dialysis for vadadustat," said John P. Butler, President and CEO of Akebia Therapeutics. "The clear and consistent data set the stage for the potential approval of vadadustat and underscore its potential as a new oral standard of care for treating patients on dialysis with anemia due to CKD, including both incident and prevalent dialysis patients, upon approval. We look forward to bringing this innovative therapy to patients on dialysis globally, upon approval, and remain on track to submit an NDA as early as possible next year." Akebia's vadadustat development program also includes PRO2TECT, the global Phase 3 program for the treatment of anemia due to CKD in adult patients not on dialysis. Results from this program will be presented at ASN Kidney Week in a late-breaking presentation on October 23, 2020. Akebia plans to submit to the U.S. Food and Drug Administration (FDA) a New Drug Application (NDA) for vadadustat for the treatment of anemia due to CKD in adult dialysis-dependent and non-dialysis dependent patients as early as possible in 2021. In addition, Akebia and its collaborator, Otsuka Pharmaceutical Co. Ltd., are working in close collaboration to prepare a Marketing Authorization Application (MAA) for submission to the European Medicines Agency (EMA) next year. Investor Briefing Webcast About the INNO2VATE Global Phase 3 Program of Vadadustat About Anemia due to Chronic Kidney Disease (CKD) About Vadadustat About Akebia Therapeutics Forward Looking Statements Investor Contact View original content to download multimedia:http://www.prnewswire.com/news-releases/akebia-presents-results-from-its-inno2vate-global-phase-3-program-demonstrated-efficacy-and-cardiovascular-safety-of-vadadustat-for-the-treatment-of-anemia-due-to-chronic-kidney-disease-in-adult-patients-on-dialysis-301158444.html SOURCE Akebia Therapeutics | ||
Company Codes: NASDAQ-NMS:AKBA |
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