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 studies
- Akebia plans to request Type A meeting and then resubmit NDA
- Akebia will host a conference call on
Tuesday, May 30at 8:30 a.m. ET
The 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.
The 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 post-approval. It further advises that data from commercial experience in
"We are extremely pleased with this outcome. The OND's letter provides guidance on a path for the resubmission of our NDA and potential approval of vadadustat for dialysis dependent patients in the
The OND suggested that Akebia request a Type A meeting with the Division to ensure alignment on the contents of the NDA resubmission. Akebia plans to request this meeting as soon as possible and expects to resubmit the NDA in the second half of 2023.
Vadadustat is currently approved for use in 33 countries. In
Akebia will host a conference call on
A live webcast of the conference call will be available via the Investors section of Akebia's website at: https://ir.akebia.com/. An online archive of the webcast can be accessed via the Investors section of Akebia's website at http://ir.akebia.com approximately two hours after the event.
Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor designed to mimic the physiologic effect of altitude on oxygen availability. At higher altitudes, the body responds to lower oxygen availability with stabilization of hypoxia-inducible factor, which can lead to increased red blood cell production and improved oxygen delivery to tissues. Vadadustat is not approved by the
For safety information, view the European Summary of Product Characteristics (SPC/SmPC) for Vafseo® (vadadustat) at https://ec.europa.eu/health/documents/community-register/2023/20230424158854/anx_158854_en.pdf and https://products.mhra.gov.uk/.
Statements in this press release regarding
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