Vadadustat shows positive results in phase 3 trials

ByMark E. Neumann

Akebia Therapeutic’ s investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor showed positive results in the first of two global phase 3 cardiovascular outcomes programs when compared to darbepoetin alfa for the treatment of anemia in patients on dialysis, company officials said.

In the INNO₂VATE trial, vadadustat demonstrated noninferiority 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) in each of two studies. Vadadustat also achieved the primary safety endpoint of the program, which was defined as noninferiority of vadadustat vs. darbepoetin alfa in time to first occurrence of major adverse cardiovascular events (MACE) across both studies, the company said.

“The INNO₂VATE study results are very compelling,” Glenn Chertow, MD, MPH, professor of medicine and chief of the division of nephrology at Stanford University and co-chair of the independent executive steering committee for the trial, said in a press release. “The greatest strength of the INNO₂VATE data is the consistency across both efficacy and all MACE components.”

The researchers enrolled 3,923 adults on dialysis with anemia due to CKD. In the two studies, patients were randomized 1:1 to receive either vadadustat or darbepoetin alfa.

John P. Butler

Each analysis was measured against noninferiority margins agreed upon with the FDA and the European Medicines Agency, according to the company.

“It is extremely rewarding to see this program yield clear, consistent, straightforward results … The team is already at work on vadadustat's new drug application (NDA), which we expect to file as quickly as possible following the top-line data readout of PRO2TECT, our global phase 3 program studying vadadustat in adult patients not on dialysis with anemia due to CKD, which we expect in mid-2020, as planned,” John P. Butler, president and CEO of Akebia, said in the release.

Reference:

https://ir.akebia.com/news-releases/news-release-details/akebia-therapeutics-announces-positive-top-line-results-global

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https://ir.akebia.com/news-releases/news-release-details/akebia-therapeutics-announces-positive-top-line-results-global

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Vadadustat shows positive results in phase 3 trials

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