Akebia: Phase 3 trial results for vadadustat reach efficacy endpoints in patients with CKD
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Akebia Therapeutics Inc. said its investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor vadadustat reached primary and key secondary efficacy endpoints in phase 3 PRO2TECT cardiovascular outcomes studies.
The company said vadadustat did not meet the primary safety endpoint of the PRO2TECT program, defined as non-inferiority vs. darbepoetin alfa in time to first occurrence of major adverse cardiovascular events (MACE), which is the composite of all-cause mortality, non-fatal myocardial infarction and non-fatal stroke across both PRO2TECT studies.
"We remain confident that we have a path toward potential approval for vadadustat in dialysis supported by positive top-line results for efficacy and safety from INNO2VATE,” John P. Butler, president and CEO of Akebia Therapeutics, said in a press release. “PRO2TECT delivered positive top-line efficacy results; however, the MACE result presents challenges to achieving our goal of bringing vadadustat to patients in the non-dialysis market. While achieving the MACE endpoint would have made our path here more straightforward, as it is in dialysis, we still believe we have a path toward approval for vadadustat in non-dialysis.”
Two studies evaluated the efficacy and safety of vadadustat vs. darbepoetin alfa for the treatment of anemia in non-dialysis adult patients. The company’s vadadustat development program also includes two other global phase 3 studies (INNO2VATE) for the treatment of anemia due to chronic kidney disease in adult patients on dialysis. The company reported positive top-line data in May.
In the PRO2TECT studies, vadadustat demonstrated non-inferiority to darbepoetin alfa as measured by a mean change in hemoglobin between baseline and the primary evaluation period (weeks 24 to 36) and secondary evaluation period (weeks 40 to 52).
Akebia said it plans to submit a new drug application for vadadustat for the treatment of anemia due to CKD in adult dialysis-dependent and nondialysis-dependent patients in 2021.
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