Daily Newsletter

28 March 2024

Daily Newsletter

28 March 2024

Akebia’s Vafseo gains FDA approval for anaemia due to CKD

The FDA decision was based on safety and efficacy data from the INNO₂VATE programme.

Vishnu Priyan March 28 2024

The US Food and Drug Administration (FDA) has approved Akebia Therapeutics‘ Vafseo (vadadustat) tablets for anaemia caused by chronic kidney disease (CKD) in adults on dialysis for a minimum of three months.

The once-daily oral medication is a hypoxia-inducible factor prolyl hydroxylase inhibitor, designed to trigger the body’s natural response to low oxygen levels and stimulate the production of erythropoietin.

Vafseo’s approval in the US follows its positive reception in 37 countries worldwide.

The FDA decision was based on safety and efficacy data from the INNO₂VATE programme and post-marketing safety data from Japan, where Vafseo has been available since August 2020.

Akebia is set to market Vafseo in the US with its experienced renal commercial team.

The company will capitalise on its partnership with speciality pharmaceuticals company CSL Vifor, which introduces innovative therapies to dialysis organisations in the US.

Akebia’s strategy is to establish Vafseo as the new oral standard of care for adult patients undergoing dialysis.

Akebia CEO John Butler stated: “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.”

In September 2023, the company received approval from Australia’s Therapeutic Goods Administration for Vafseo for the same indication.

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