FDA Rejects Akebia Therapeutics' Vadadustat For CKD-Associated Anemia - Akebia Therapeutics (NASDAQ:AKBA)

The FDA has issued a complete response letter (CRL) to Akebia Therapeutics Inc's 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 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.