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Akebia’s Vafseo gains FDA approval for anaemia due to CKD
2024-03-28
上市批准
Akebia plans to establish Vafseo as the new oral standard of care for adult patients undergoing dialysis. Credit: Tyler Olson / Shutterstock.com.
The oncFood and Drug Administration (FDA)ia-inducible fAkebia TherapeuticsylVafseohivadadustatigned to trigganaemiabody’s natuchronic kidney disease (CKD)evels and stimulate the production of erythropoietin.
Vafseo’s approval in the US follows hypoxia-inducible factor prolyl hydroxylase inhibitorhypoxia-inducible factor prolyl hydroxylasedwide.erythropoietin
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.
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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 strateAstraZenecatabTruqapafseo Faslodexew orbreast cancerf 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 CSL Vifore 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.”
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