U.S. FDA Approves Akebia’s Vadadustat For CKD-induced Anemia

On March 27, the U.S. Food and Drug Administration (FDA) granted approval to Akebia Therapeutics’ (AKBA.O) drug, vadadustat, for the treatment of anemia resulting from chronic kidney disease (CKD) in patients undergoing dialysis. This announcement marks a significant development in the realm of kidney disease treatment. Vadadustat will be marketed under the brand name Vafseo.

Previously, the FDA had declined to approve vadadustat due to safety concerns, particularly its potential to increase the risk of blood clot formations and liver injuries. However, the FDA’s recent decision signals a positive shift, suggesting that Akebia could explore conducting new studies to demonstrate a favorable benefit-risk profile for the drug.

Vadadustat belongs to a class of drugs known as Hypoxia-inducible factor–prolyl hydroxylase (HIF-PH) inhibitors. These oral medications are designed to stimulate the production of red blood cells by mimicking the body’s response to high altitudes. Another HIF-PH inhibitor, daprodustat, developed by GlaxoSmithKline, has already been approved by the FDA based on promising results from late-stage trials, where it demonstrated efficacy in improving hemoglobin levels.

Akebia’s vadadustat has already garnered approval in 37 countries, including Europe, Australia, and Taiwan, for treating symptomatic anemia associated with CKD in adult patients undergoing chronic dialysis. In Japan, vadadustat is approved for treating anemia in both dialysis-dependent and non-dialysis dependent adult patients with CKD.

Analysts predict a promising trajectory for vadadustat, estimating its launch in the second half of this year and projecting peak sales of $954 million by 2031. Anemia is a prevalent complication of CKD, a condition characterized by inefficient blood filtration by the kidneys, leading to the accumulation of waste and fluid in the body. According to the Centers for Disease Control and Prevention, approximately 35.5 million adults in the United States are estimated to have CKD, highlighting the significance of effective treatment options such as vadadustat in managing this condition.

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