Reata Pharmaceuticals Inc.'s diabetic kidney disease medicine bardoxolone methyl received priority review designation from the Japanese Ministry of Health, Labour and Welfare.
The Irving, Texas, based biopharmaceutical company said that Kyowa Hakko Kirin Co. Ltd., its licensee for the medicine in Japan, received the Sakigake priority review designation.
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.
In December 2009, Reata granted Kyowa Hakko the exclusive license to develop and commercialize bardoxolone in renal disease and certain other indications in Japan, China, Taiwan, South Korea and Southeast Asia.
Reata said Kyowa Hakko is planning to initiate a phase 3 trial in diabetic kidney disease during 2018 in Japan to validate the efficacy and safety of bardoxolone methyl.
The two companies also collaborating in Japan in an ongoing phase 3 study, named Cardinal, for bardoxolone to treat Alport syndrome, a severe, hereditary form of kidney disease.