The approval is supported by the safety and efficacy data from the INNO2VATE programme and post-marketing safety data from Japan where Vafseo has been available since August 2020
Akebia's Vafseo gets FDA nod for anaemia due to CKD. (Credit: Michal Jarmoluk from Pixabay)
Akebia Therapeutics has received approval from the US Food and Drug Administration (FDA) for Vafseo (vadadustat) tablets to treat anaemia caused by chronic kidney disease (CKD).
The FDA’s approval is for the drug’s use in CKD adult patients, who have been on dialysis for at least three months.
Vafseo is a once-daily oral inhibitor of hypoxia-inducible factor prolyl hydroxylase (HIF-PH).
Approved for use in 37 countries, the drug is designed to activate physiologic response to boost haemoglobin and red blood cell production for anaemia management.
Akebia Therapeutics resubmitted the new drug application (NDA) for the drug in September last year as earlier it was rejected by the American health regulator citing certain safety concerns.
The approval, which the company has now secured, is based on safety and efficacy data from the INNO2VATE programme and an evaluation of post-marketing safety data from Japan where Vafseo has been available since August 2020.
INNO2VATE randomised around 7,500 patients across two Phase 3 trials in a 1:1 ratio to receive either vadadustat or darbepoetin alfa.
The clinical programme found that vadadustat was non-inferior to darbepoetin alfa in terms of cardiovascular safety and correction and maintenance of haemoglobin concentrations.
Akebia Therapeutics CEO John Butler said: “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.”
Akebia Therapeutics plans to leverage its affiliation with CSL Vifor to market Vafseo in the US.
CSL Vifor is an American speciality pharmaceutical firm working to bring new therapies to dialysis organisations in the country.
Akebia Therapeutics, which secured $55m in term loan financing in January, intends to make Vafseo a new oral standard of care for adult dialysis patients.