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Tuesday, March 12, 2019

Akebia Therapeutics (AKBA) : positive top-line results from two pivotal Phase 3 studies

Akebia Therapeutics (AKBA) : Positive Top-Line Results from Two Pivotal Phase 3 Studies of Vadadustat in Japanese Patients with Anemia Due to Chronic Kidney Disease 

  • Co announced positive top-line results from two phase 3 active-controlled pivotal studies evaluating vadadustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), in Japanese subjects with anemia due to chronic kidney disease (CKD).
  • These studies were conducted by Akebia's development and commercialization collaboration partner in Japan, Mitsubishi Tanabe Pharma Corporation (MTPC).
  • Each study, one in non-dialysis dependent subjects and one in hemodialysis-dependent subjects, met its primary endpoint.
  • In addition, results from two phase 3 single-arm studies conducted by MTPC in peritoneal dialysis subjects and hemodialysis subjects further support vadadustat's potential in these indications.
  • MTPC expects to submit a Japanese New Drug Application in 2019.
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