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FDA Provides Akebia Therapeutics a Path Forward for Vadadustat
FDA denies formal dispute resolution, but outlines path to resubmit NDA for dialysis-dependent patients without new clinical studiesAkebia plans to request
About this update from Akebia Therapeutics, Inc.
[{"type":"text","content":"FDA denies formal dispute resolution, but outlines path to resubmit NDA for dialysis-dependent patients without new clinical studiesAkebia plans to request Type A meeting and then resubmit NDAAkebia will host a conference call on Tuesday, May 30 at 8:30 a.m. ETCAMBRIDGE, Mass., May 30, 2023 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that the company received a written response from the Office of New Drugs (OND) of the U.S. Food and Drug Administration (FDA) to Akebia's Formal Dispute Resolution Request (FDRR) regarding the Complete Response Letter (CRL) received in March 2022 for vadadustat. The letter from the OND stated the company's appeal was denied; however, the letter provided a path forward for the company to resubmit the new drug application (NDA) for vadadustat for the treatment of anemia due to chronic kidney disease (CKD) for dialysis dependent patients. The letter addressed issues outlined in the CRL, provided feedback and conclusions on those issues, and outlined information to be included in an NDA resubmission, which did not include the generation of additional clinical data.\n\n \n \n \n \n \n \n\n \nThe CRL raised a concern regarding the increased risk of thromboembolic events, driven by vascular access thrombosis (VAT). While not dismissing the potential safety signal, the OND indicated that the extent of the increase in potential risk is not large and it may be a reasonable conclusion that the increase in VAT events can be managed as a labeling issue.\nThe CRL noted a concern about the risk for drug-induced liver injury (DILI) and concern that ongoing monitoring would be less uniformly implemented once commercially available than in the clinical trial. The OND concluded that while DILI remains a concern, the DILI signal appears modest in intensity and is potentially manageable with appropriate monitoring. The OND also acknowledged Akebia's comments that such monitoring is routine among dialysis patients, and therefore rigorous testing consistent with labeled recommendations is likely to be fully implemented. The OND letter states that commercial experience would be highly valuable in considering that DILI can be handled through labeling and that DILI will be an unusual event po...