The studies of vadadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, were conducted by its commercialization collaboration partner in
Mitsubishi Tanabe expects to submit a new drug application in 2019 in Japan.
“These data provide further confirmation of vadadustat’s potential to meaningfully transform the treatment paradigm for patients with anemia due to chronic kidney disease,” Akebia CEO
Phase 3 outcomes
A phase 3 randomized, open-label, active-controlled correction and conversion study for non-dialysis dependent subjects met its primary endpoint, with the mean hemoglobin level at week 20 and week 24 at 11.66 grams per deciliter for vadadustat-treated subjects, compared with 11.93 for other subjects. Another Phase 3 study of hemodialysis subjects also met its primary endpoint, with the mean hemoglobin level at week 20 and week 24 at 10.61 grams per deciliter, compared with 10.65 for other subjects.
Anemia is common in patients with chronic kidney disease, and in
Vadadustat, if approved for marketing, would provide patients with a once-daily oral treatment option and has the potential to set a new standard of care, the company said.
Contact Dennis Fitzgerald at [email protected]rs.com