Akebia (AKBA) Submits NDA to FDA for Vadadustat for Treatment of Anemia Due to Chronic Kidney Disease in Adult Patients on Dialysis and Not on Dialysis
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Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose of bettering the lives of people impacted by kidney disease, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for vadadustat, Akebia's investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the treatment of anemia due to chronic kidney disease (CKD) in both adult patients on dialysis and adult patients not on dialysis.
"The submission of the vadadustat NDA for the treatment of anemia due to CKD in both adult patients on dialysis and not on dialysis marks a significant milestone not only for Akebia and our partners, but also for patients living with this disease," stated John P. Butler, Chief Executive Officer of Akebia. "The Akebia team and our collaborator, Otsuka, did an outstanding job preparing this comprehensive submission, which includes substantial data from over 8,000 patients across 36 clinical trials of vadadustat. We look forward to working with the FDA during the review process, and are excited to continue collaborating with our partners to advance vadadustat for the benefit of patients, subject to regulatory approval."
Based on standard FDA review timelines, the FDA has a 60-day period to determine whether the NDA is complete and acceptable for review. The Company's NDA submission did not include a Priority Review Voucher.
Otsuka Pharmaceutical Co. Ltd. (Otsuka) is working in close collaboration with Akebia to prepare a Marketing Authorization Application (MAA) for vadadustat for submission to the European Medicines Agency (EMA), expected this year.
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