Akebia Therapeutics, Inc. (NASDAQ: AKBA) has announced the FDA approval of 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. 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. The approval is significant as it provides an alternative treatment option for the hundreds of thousands of Americans on dialysis who are diagnosed with anemia due to CKD.
Vafseo is now approved in 37 countries and its approval for the treatment of anemia due to CKD in adults who have been receiving dialysis for at least three months 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.
Approximately 500,000 adult patients in the U.S. on dialysis suffer from anemia due to CKD, which may be associated with many adverse clinical outcomes. The burden of managing uncontrolled anemia in CKD patients can be substantial, both in terms of healthcare costs and the impact on patients, healthcare providers, and caregivers. Currently, most CKD patients are treated for anemia with injectable erythropoiesis-stimulating agents mostly administered at dialysis centers.
Akebia intends to commercialize Vafseo in the U.S. with its established commercial team that has deep renal experience and by leveraging its relationship with CSL Vifor, an industry leader in bringing innovative therapies to U.S. dialysis organizations. The company plans to execute a launch strategy to drive Vafseo toward the goal of becoming a new oral standard of care for adult dialysis patients.
Today the company's shares have moved 1.1% to a price of $2.27. Check out the company's full 8-K submission here.
