Akebia says FDA denied appeal for kidney disease candidate
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Akebia Therapeutics (NASDAQ:AKBA) announced Tuesday that the FDA denied its appeal over the agency's decision to reject the company's marketing application for kidney disease candidate vadadustat.
However, the agency's Office of New Drugs (OND) has guided the company on how to resubmit its new drug application (NDA) for vadadustat targeted at anemia due to chronic kidney disease (CKD) for patients dependent on dialysis.
Responding to Akebia's (AKBA) Formal Dispute Resolution Request (FDRR), FDA's OND unit has addressed the issues outlined in the Complete Response Letter, including the increased risk of thromboembolic events and drug-induced liver injury (DILI).
Without dismissing the safety signals, the FDA staffers have indicated that vascular access thrombosis (VAT), a reason for the higher risk of thromboembolic events, can be managed as a labeling issue.
The ODA has also indicated that appropriate monitoring would help manage DILI, and data from Japan would be important to assess this risk further.
In Japan, Akebia (AKBA) markets vadadustat as Vafseo in partnership with Mitsubishi Tanabe Pharma Corporation.
The regulators have suggested that the company request a Type A meeting with the OND. Akebia (AKBA) intends to forward this request "as soon as possible" and plans to resubmit the NDA in H2 2023.