Japanese drugmaker Eisai (TYO: 4523) today announced that it has received approval for Urece (dotinurad) from the National Medical Products Administration (NMPA) in China as a treatment for gout patients with hyperuricemia.
This approval is based on the results of a multicenter, active-controlled, double-blind, parallel-group, randomized, Phase III study conducted by Eisai in China. In this study, 451 gout patients were randomized into either the dotinurad group or febuxostat group in a 1:1 ratio.
The results of this study showed that the proportion of subjects with serum uric acid levels of 6.0 mg/dL or less at 24 weeks, which was the primary endpoint, was 73.6% [95% confidence interval (CI): 67.8, 79.5] in the dotinurad group and 38.1% [95% CI: 31.6, 44.5] in the febuxostat group, confirming the statistical superiority of dotinurad 4mg over febuxostat 40mg (difference of proportion 35.87% [95% CI: 27.36, 44.37]).
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