Eisai’s (TYO: 4523) China unit has announced that it has received marketing approval from the National Medical Products Administration (NMPA) of China for its Urece (dotinurad), a uric acid excretion promoting drug. This approval allows the use of Urece to treat gout patients with hyperuricemia in China.
Phase III Study Results in China
In a Phase III study conducted in China, the efficacy of dotinurad was compared to febuxostat. The proportion of patients with blood uric acid levels less than or equal to 6 mg/dL (360 μ mol/L) after 24 weeks of treatment with dotinurad 4mg was 73.6%, significantly higher than the 38.1% observed in the febuxostat 40mg group. This indicates the potential superiority of dotinurad in managing uric acid levels in gout patients.
Safety Profile and Clinical Study Outcomes
The safety profile of dotinurad was also evaluated in a Phase III study conducted in Japan. After 58 weeks of treatment, dotinurad had no significant effect on liver and kidney function, with a compliance rate of uric acid at 100.00%. The drug did not require dosage adjustments for patients with mild to moderate renal insufficiency, and no serious cardiovascular adverse reactions were observed across multiple clinical studies.
Dotinurad’s Development and Marketing Rights
Dotinurad, a selective urate transporter 1 (URAT1) inhibitor, was originally developed by Fuji Yakuhin Co Ltd. The Japanese firm transferred its exclusive development and sales rights to Eisai in China and five ASEAN member countries (Indonesia, Malaysia, Myanmar, Philippines, and Thailand) through deals in February 2020 and August 2021. The drug has been approved for marketing in Japan and Thailand in 2020 and 2024, respectively, further expanding its reach in the region.
