US biopharmaceutical company Akebia Therapeutics Inc (Nasdaq: AKBA) announced on Wednesday that it has received approval from the US Food and Drug Administration (FDA) for 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, a once-daily oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, activates the physiologic response to hypoxia to stimulate endogenous production of erythropoietin to handle anaemia. It is now approved in 37 countries.
The FDA's approval was based on efficacy and safety data from the INNO2VATE programme and an evaluation of post marketing safety data from Japan, where Vafseo was introduced in August 2020.
John P Butler, Akebia chief executive officer, 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."
Pierre Fabre Pharmaceuticals reports FDA acceptance and Priority Review of Tabelecleucel BLA
Bavarian Nordic's chikungunya vaccine receives validation from EMA for accelerated review
Atara Biotherapeutics gains FDA Priority Review for tabelecleucel
Hyperfine secures FDA clearance for faster brain imaging software
Silo Pharma agrees Alzheimer's drug licence
Kyverna's KYV-101 granted FDA Regenerative Medicine Advanced Therapy designation
Camurus reports positive Phase 3 ACROINNOVA 2 results
Acurx Pharmaceuticals presents positive Ibezapolstat Phase 2 clinical trial results for CDI