FDA Approves For Akebia Therapeutics' Vafseo For Kidney Disease Associated Anemia

Wednesday, the FDA approved Akebia Therapeutics Inc AKBA Vafseo (vadadustat) tablets for anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months. 

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.

The approval of Vafseo is based on efficacy and safety data from the INNO2VATE program and an assessment of post-marketing safety data from Japan, where VAFSEO was launched in August 2020. 

Results from the INNO2VATE program were published in the New England Journal of Medicine. 

Approximately 500,000 adult patients in the U.S. on dialysis suffer from anemia due to CKD.

Akebia intends to commercialize Vafseo in the U.S. with its established commercial team. 

In line with the approved label, Akebia will execute a launch strategy to drive Vafseo toward the goal of becoming a new oral standard of care for adult dialysis patients.

Read Next: Analyst Highly Confident In Akebia Therapeutics’ Kidney Disease-Associated Anemia Drug, Stock Soars.

Citing, H.C. Wainwright analyst, Reuters noted that with an estimated launch of Vafseo in the second half of this year, peak sales are expected to reach $954 million in 2031.

Price Action: AKBA shares are up 18.8% at $2.66 during the premarket session on the last check Thursday.