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# Akebia Therapeutics Resubmitting Anemia NDA
- URL: https://www.fdaweb.com/akebia-therapeutics-resubmitting-anemia-nda/
- Published: 2023-05-30T12:00:00.000Z
- Updated: 2026-09-14T18:34:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154570

CDER’s Office of New Drugs has denied an Akebia Therapeutics dispute resolution request following its receipt of a 3/22 [complete response letter](https://www.fdaweb.com/complete-response-for-akebia-vadadustat/) (CRL) for vadadustat, but the company says it was offered a “path forward” to resubmit the NDA, indicated for treating anemia due to chronic kidney disease (CKD) in 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,” the company says.

The CRL cited concerns about an 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,” Akebia says. It also 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. “The OND concluded that while DILI remains a concern, the DILI signal appears modest in intensity and is potentially manageable with appropriate monitoring,” the company says. “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.”

Additionally, according to Akebia, OND said the drug’s commercial experience would be valuable in considering whether DILI can be handled through labeling and requested data from post-approval experience in Japan that would help FDA assess the risk of DILI. “Accordingly, Akebia plans to include post-approval data from Japan in the NDA resubmission, where tens of thousands of Japanese patients with CKD have been exposed to vadadustat to date,” according to the company, adding that after two years on the market, there have been no DILI reports in Japan.

Akebia said OND also suggested that it request a Type A meeting with the review division to make sure there is an agreement on the contents of the NDA resubmission. Akebia plans to request the meeting soon and expects to resubmit the NDA in the second half of the year.