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Reata Announces Kyowa Hakko Kirin Received SAKIGAKE Priority Review Designation for Bardoxolone Methyl in Japan
Apr. 03, 2018 08:54AM PST
Pharmaceutical InvestingReata Pharmaceuticals (Nasdaq:RETA) a clinical-stage biopharmaceutical company, announced that its licensee, Kyowa Hakko Kirin received designation under the Priority Review and Designation System, or SAKIGAKE Designation, by the Japanese Ministry of Health, Labour and Welfare, for bardoxolone methyl (bardoxolone) for the treatment of diabetic kidney disease (DKD). As quoted in the press release: The Priority …
Reata Pharmaceuticals (Nasdaq:RETA) a clinical-stage biopharmaceutical company, announced that its licensee, Kyowa Hakko Kirin received designation under the Priority Review and Designation System, or SAKIGAKE Designation, by the Japanese Ministry of Health, Labour and Welfare, for bardoxolone methyl (bardoxolone) for the treatment of diabetic kidney disease (DKD).
As quoted in the press release:
The Priority Review and Designation System in Japan is designed to accelerate the development of new treatments with the potential to demonstrate significant improvements in efficacy over existing therapies. Designated products are eligible to receive prioritized consultation services and premarket pharmaceutical affairs review by the Japanese regulatory authority.
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