Kyowa Kirin announces discontinuation of developmentof bardoxolone methyl in Japan,
Kyowa Kirin Co., Ltd. announces the discontinuation of the clinical development program for bardoxolone methyl (RTA 402), a small-molecule compound licensed from Reata Pharmaceuticals, Inc.
Kyowa Kirin has determined that it is difficult to file an application for manufacturing and marketing approval of RTA 402 for diabetic kidney disease in Japan and decided to discontinue the development for the indication. In addition, Kyowa Kirin will withdraw the application for manufacturing and marketing approval of RTA 402 for Alport Syndrome filed in July 2021 in Japan and discontinue development for this indication. Further, Kyowa Kirin has initiated discussions with Reata to end its participation as an In-County Clinical Caretaker CCC for the clinical trials of RTA 402 for Alport Syndrome and Autosomal Dominant Polycystic Kidney Disease.
Kyowa Kirin signed a license agreement with Reata for the exclusive rights to develop and commercialize RTA 402 for renal diseases and certain other indications in Japan, China, Taiwan, South Korea, and Southeast Asian countries on December 24, 2009.
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