FDA Approves Akebia's Vafseo for Anemia in CKD Patients on Dialysis

Akebia Therapeutics has received approval from the U.S. Food and Drug Administration (FDA) for Vafseo (vadadustat) tablets. This new medication is indicated for the treatment of anemia associated with chronic kidney disease (CKD) in adults undergoing dialysis for a minimum of three months. Vadadustat functions as an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), which mimics the body's response to low oxygen levels and promotes the production of erythropoietin.

The FDA's decision is grounded on the results of the INNO₂VATE program, which provided efficacy and safety data, along with post-market safety data gathered from Japan, where the drug was previously launched. Vafseo is now approved in 37 countries worldwide, including Australia, where it recently gained approval from the Therapeutic Goods Administration for the same treatment indication.

CSL Vifor has secured an exclusive license to market Vafseo to Fresenius Kidney Care dialysis centers and other third-party dialysis organizations within the U.S., a move that could potentially impact approximately 60% of U.S. dialysis patients. Akebia Therapeutics plans to establish Vafseo as the new oral standard of care for anemia in adult dialysis patients, utilizing its established commercial team and leveraging its relationship with CSL Vifor, a specialist in innovative therapies for the dialysis industry. The company has announced a conference call scheduled for March 28 at 8:00 am ET to discuss the launch and future strategies for Vafseo.