Research & Development
Akebia Therapeutics' Vafseo (vadadustat) Tablets approved by US FDA
28 March 2024 -

US biopharmaceutical company Akebia Therapeutics Inc (Nasdaq: AKBA) announced on Wednesday that it has received approval from the US Food and Drug Administration (FDA) for Vafseo (vadadustat) Tablets for the treatment of anaemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months.

Vafseo, a once-daily oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, activates the physiologic response to hypoxia to stimulate endogenous production of erythropoietin to handle anaemia. It is now approved in 37 countries.

The FDA's approval was based on efficacy and safety data from the INNO2VATE programme and an evaluation of post marketing safety data from Japan, where Vafseo was introduced in August 2020.

John P Butler, Akebia chief executive officer, said: "With the approval of Vafseo in the US, we're proud to deliver an alternative treatment option for the hundreds of thousands of Americans on dialysis who are diagnosed with anaemia due to CKD. At Akebia we are committed to kidney patients, a dedication that has driven our team to achieve this milestone. We believe this commitment uniquely positions the company to execute a successful launch designed to drive toward a potential new oral standard of care for dialysis patients."