FDA rejects Akebia Therapeutics’ anemia drug for patients with chronic kidney disease

The FDA rejected Akebia Therapeutics’ anemia drug vadadustat for use in patients with chronic kidney disease, citing concerns about vascular access complications and liver toxicity.
Akebia received a complete response letter (CRL) from the FDA on March 30 to its new drug application (NDA) for vadadustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor under review for the treatment of anemia due to CKD.
“We are extremely disappointed to receive a CRL for vadadustat, a therapy that has the potential to help patients with anemia due to CKD,” John P.

The FDA rejected Akebia Therapeutics’ anemia drug vadadustat for use in patients with chronic kidney disease, citing concerns about vascular access complications and liver toxicity.
Akebia received a complete response letter (CRL) from the FDA on March 30 to its new drug application (NDA) for vadadustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor under review for the treatment of anemia due to CKD.
“We are extremely disappointed to receive a CRL for vadadustat, a therapy that has the potential to help patients with anemia due to CKD,” John P.