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FDA Rejects Benefit of Vadudastat for Anemia due to Chronic Kidney Disease

The agency cited an increased risk of thromboembolic events driven by vascular access thrombosis in dialysis patients and increased risk of drug-induced liver injuries.

The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for vadadustat, a potential treatment for anemia due to chronic kidney disease (CKD).

The CRL, issued to Akebia Therapeutics, is based on data the FDA said does not support a favorable benefit-risk assessment of the treatment for dialysis and non-dialysis patients with safety concerns over the failure to meet non-inferiority in MACE in the non-dialysis patient population.

There was also an increased risk of thromboembolic events driven by vascular access thrombosis in dialysis patients and an increased risk of drug-induced liver injuries.

The company is able to rectify some of the concerns outlined in the letter through new clinical trials.

"We are extremely disappointed to receive a CRL for vadadustat, a therapy that has the potential to help patients with anemia due to CKD. We continue to believe the data are supportive of a positive benefit-risk assessment of vadadustat for patients with anemia due to CKD, particularly in dialysis patients," said John P. Butler, Chief Executive Officer of Akebia, in a statement. "Despite this setback, we continue to work toward our purpose to better the lives of people impacted by kidney disease."

Vadadustat is an investigational oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor aimed at mimicking the physiologic effect of altitude on oxygen availability.