Akebia receives FDA approval of Vafseo
The US Food and Drug Administration (FDA) has approved Vafseo (vadadustat) tablets for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months.
Developed by kidney disease specialist Akebia Therapeutics (Nasdaq: AKBA), Vafseo is a once-daily oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor that activates the physiologic response to hypoxia to stimulate endogenous production of erythropoietin to manage anemia.
Vafseo is now approved in 37 countries, said Akebia, whose shares closed up 12% following the announcement yesterday, and gained a further 4% to $2.33 in pre-market trading.
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