Akebia's Vadadustat Misses In Non-Dialysis CKD, But Filings Still Planned For 2021

 
• By Jessica Merrill
  
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HIF-PHI inhibitor failed to show non-inferiority to ESAs in the primary cardiovascular safety endpoint of a Phase III program for the treatment of anemia due to chronic kidney disease.

Kidney Disease - Printed Diagnosis with Red Pills, Injections and Syringe. Medical Concept with Selective Focus.
Akebia hoped vadadustat would show a safety benefit in non-dialysis CDK versus ESAs • Source: Shutterstock

Akebia Therapeutics, Inc../Otsuka Pharmaceutical Co. Ltd.'s Phase III program for vadadustat disappointed in patients with anemia due to chronic kidney disease (CKD) who aren't on dialysis, setting up a more challenging road to approval in a broad CKD setting. The companies announced mixed data from the two trials on 3 September.

Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) Akebia is developing as an oral alternative to erythropoiesis-stimulating agents...

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