Akebia Therapeutics, Inc. (Nasdaq:AKBA) today 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.
“Collectively, these data provide further confirmation of vadadustat’s potential to meaningfully transform the treatment paradigm for patients with anemia due to CKD,” said John P. Butler, President and Chief Executive Officer of Akebia. “These results add to our dataset demonstrating the potential for vadadustat to effectively manage hemoglobin levels in both dialysis-dependent and non-dialysis dependent patients, including those who convert from erythropoiesis stimulating agents.”
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