Japan becomes first country to approve vadadustat for treatment of CKD-related anemia
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Akebia Therapeutics Inc. recently announced that Japan has approved vadadustat for the treatment of anemia due to chronic kidney disease. This marks the first regulatory approval of the drug, according to a company press release.
Vadadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, showed positive results in two phase 3 trials, inciting the company to reveal plans for the development and commercialization of the drug in a variety of regions (including in the United States, Europe, Australia and the Middle East). Healio Nephrology reported on these results in May of 2020.
Mitsubishi Tanabe Pharma Corporation (MTPC) serves as Akebia’s collaboration partner in Japan, according to the release, and has obtained manufacturing and marketing approval of vadadustat for patients who are either dialysis dependent or nondialysis dependent.
“Today’s announcement represents the first regulatory approval of vadadustat and is a significant step forward for patients with anemia due to CKD in Japan,” John P. Butler, president and CEO of Akebia, said. “We believe this milestone marks the beginning of the next phase of Akebia's growth story and we are excited to support our collaboration partner, MTPC, with the expected commercialization of vadadustat in Japan later this year.”
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