FDA Rejects Akebia Therapeutics' Vadadustat For CKD-Associated Anemia

Vandana Singh
1 min read
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In this article:

  • The FDA has issued a complete response letter (CRL) to Akebia Therapeutics Inc's (NASDAQ: AKBA) marketing application (NDA) for vadadustat for anemia due to chronic kidney disease (CKD).

  • Vadadustat is an investigational oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor.

  • The FDA issues a CRL to indicate that the review cycle for an application is complete and that the application is not ready for approval in its present form.

  • The FDA concluded that the data in the marketing application does not support a favorable benefit-risk assessment of vadadustat for dialysis and non-dialysis patients.

  • The FDA expressed safety concerns noting failure to meet non-inferiority in MACE in the non-dialysis patient population, the increased risk of thromboembolic events driven by vascular access thrombosis in dialysis patients, and the risk of drug-induced liver injury.

  • The CRL stated that Akebia could potentially explore ways to potentially demonstrate a favorable benefit-risk assessment through new clinical trials.

  • In October 2021, Akebia's collaboration partner, Otsuka Holdings Co Ltd (OTC: OTSKY), submitted an initial marketing application for vadadustat in Europe. The review is ongoing.

  • In Japan, vadadustat is approved as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis-dependent adult patients.

  • Price Action: AKBA shares are down 67.60% at $0.79 on the last check Wednesday.

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