- 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.
