Akebia Presents Results from its PRO2TECT Global Phase 3 Program of Vadadustat for the Treatment of Anemia due to Chronic Kidney Disease in Adult Patients Not on Dialysis During Late-Breaking Session at American Society of Nephrology Kidney Week 2020 Reimagined
October 23, 2020 at 11:15 AM EDT
CAMBRIDGE, Mass., Oct. 23, 2020 /PRNewswire/ -- Akebia Therapeutics, Inc. (Nasdaq: AKBA), today announced the presentation of clinical data from its PRO2TECT global Phase 3 program that evaluated the efficacy and safety of vadadustat, Akebia's investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), versus darbepoetin alfa for the treatment of anemia due to chronic kidney disease (CKD) in adult patients not on dialysis, at American Society of Nephrology Kidney Week 2020 Reimagined (ASN Kidney Week). As previously announced, vadadustat achieved the primary and key secondary efficacy endpoints in each of the two studies in the program, but did not meet the primary safety endpoint. Newly presented pre-specified regional analyses of the PRO2TECT program show vadadustat demonstrated no clinically meaningful increase in cardiovascular risk compared to darbepoetin alfa in analyses of MACE, expanded MACE and all-cause mortality in U.S. patients treated to a target hemoglobin (Hb) range of 10 to 11 g/dL, consistent with U.S. treatment guidelines.
"The PRO2TECT results show that orally administered vadadustat achieved both primary and secondary efficacy endpoints in patients not on dialysis with anemia associated with CKD. The newly presented analyses showed that there were regional differences with respect to MACE, expanded MACE and all-cause mortality, consistent with well-known, differing regional hemoglobin treatment target guidelines," said Glenn Chertow, M.D., M.P.H., Professor of Medicine, Chief, Division of Nephrology at Stanford University, and Co-Chair of the independent Executive Steering Committee for PRO2TECT and INNO2VATE. "The analyses also confirm there was no increased cardiovascular risk associated with vadadustat across the U.S. patients treated to a target hemoglobin range of 10 to 11 g/dL."
The PRO2TECT data are being presented today during a late-breaking oral presentation, titled "Global Phase 3 Clinical Trials of Vadadustat vs Darbepoetin Alfa for Treatment of Anemia in Patients with Non-Dialysis-Dependent Chronic Kidney Disease" (Abstract FR-OR54) at ASN Kidney Week. Akebia's vadadustat development program also includes INNO2VATE, the global Phase 3 program for the treatment of anemia due to CKD in adult patients on dialysis. Results from this program were presented at ASN Kidney Week in an oral presentation on October 22, 2020.
Highlights of the PRO2TECT ASN Kidney Week Presentation:
"The newly presented pre-specified analyses of PRO2TECT showed that vadadustat had no clinically meaningful increase in cardiovascular risk in U.S. patients not on dialysis treated to a target hemoglobin range of 10 to 11 g/dL, consistent with U.S. treatment guidelines. Upon submission of our NDA for vadadustat, we expect that the potential approval of vadadustat as a treatment for patients not on dialysis will be a review issue for the FDA, and we continue to believe that these important analyses, together with the totality of data from our Phase 3 program, will inform that review," said John P. Butler, President and CEO of Akebia Therapeutics. "We remain confident that vadadustat has a straightforward path to potential approval for the treatment of patients on dialysis, globally."
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 together to further analyze these study results to support a Marketing Authorization Application (MAA) for submission to the European Medicines Agency (EMA) next year.
Investor Briefing Webcast
About the PRO2TECT Global Phase 3 Program of Vadadustat
About Anemia due to Chronic Kidney Disease (CKD)
About Akebia Therapeutics
Forward Looking Statements
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