FDA approves new treatment option for anaemia due to kidney disease

Dialysis machine

The US Food and Drug Administration (FDA) has approved 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 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 anaemia. Vafseo is now approved in 37 countries.

“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,” said John Butler, Chief Executive Officer of Akebia. “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.”

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

Approximately 500,000 adult patients in the US on dialysis suffer from anaemia due to CKD1, which may be associated with many adverse clinical outcomes. The burden of managing uncontrolled anaemia in CKD patients can be substantial, both in terms of healthcare costs and the impact on patients, healthcare providers and caregivers.

Diana Spencer, Senior Digital Content Editor, DDW

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