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Akebia Therapeutics Announces Collaboration Partner's Submission of Supplemental New Drug Application for Use of Riona® (ferric citrate hydrate) to Treat Adult Patients with Iron Deficiency Anemia in Japan
CAMBRIDGE, Mass., May 18, 2020 /PRNewswire/ -- Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company focused on the development and
About this update from Akebia Therapeutics, Inc.
[{"type":"text","content":"CAMBRIDGE, Mass., May 18, 2020 /PRNewswire/ -- Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company focused on the development and commercialization of therapeutics for people living with kidney disease, announced today that its collaboration partner, Japan Tobacco, Inc. (JT), has filed a supplemental New Drug Application (NDA) with the Pharmaceuticals and Medical Devices Agency (PMDA) seeking an additional indication for Riona® Tablets 250mg (generic name in Japan: ferric citrate hydrate) to treat adult patients with iron deficiency anemia (IDA) in Japan. JT and its subsidiary, Torii Pharmaceutical Co., Ltd. (Torii), made a public announcement, which is available here: https://www.torii.co.jp/en/release/2020/20200515_E1.pdf. \n\n \n \n \n \n \n \n\n \nThe NDA is based on JT and Torii's Phase 3 clinical study and other clinical studies in adult patients with IDA in Japan. To access the complete public announcement on the Phase 3 study from JT and Torii, please visit: https://www.jt.com/media/news/2019/pdf/20190709_E01.pdf. \nRiona was approved in Japan in 2014 as an oral treatment for the improvement of hyperphosphatemia in patients with chronic kidney disease (CKD) both on dialysis and not on dialysis. Ferric citrate is approved and marketed in the United States by Akebia under the trade name Auryxia® (ferric citrate) for the control of serum phosphorus levels in adult patients with CKD on dialysis and for the treatment of IDA in adult patients with CKD not on dialysis.\n\"IDA can have a significant impact on the health and quality of life of people living with kidney disease. As an oral drug, Auryxia enables CKD patients not on dialysis, a high-risk population, to be treated for IDA while remaining safely at home,\" said Michel Dahan, Senior Vice President and Chief Operating Officer of Akebia. \"We congratulate JT and Torii on their work and are excited by their progress toward expanding Riona's label to treat adult patients with IDA in Japan.\"\nThe hyperlinks in this release do not form a part of this release.\nAbout Akebia Therapeutics\nAkebia Therapeutics, Inc. is a fully integrated biopharmaceutical company focused on the development and commercialization of therapeutics for people living with kidney disease. The Company was founded in 2007 and is headquartered in Cambridge, Massachusetts. For more infor...