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Kenny Walter is an editor with HCPLive. Prior to joining MJH Life Sciences in 2019, he worked as a digital reporter covering nanotechnology, life sciences, material science and more with R&D Magazine. He graduated with a degree in journalism from Temple University in 2008 and began his career as a local reporter for a chain of weekly newspapers based on the Jersey shore. When not working, he enjoys going to the beach and enjoying the shore in the summer and watching North Carolina Tar Heel basketball in the winter.
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.