The Center for Drug Evaluation (CDE) in China has indicated on its website that it has accepted for review the New Drug Application (NDA) filed by Japan-based Eisai (TYO: 4523) for its drug Urece (dotinurad). This marks a significant step towards potentially bringing the uric acid excretion promoting drug to the Chinese market. Urece was initially approved for marketing in Japan in 2020 for the treatment of hyperuricemia and gout.
Dotinurad, a selective urate transporter 1 (URAT1) inhibitor, functions by inhibiting the reabsorption of uric acid in the kidneys, thereby reducing blood uric acid levels. The drug’s selectivity allows it to inhibit URAT1 in the proximal tubules of the kidney without impacting the function of uric acid excretion factors ABCG2 and OAT1/3. This results in a more efficient lowering of blood uric acid levels compared to non-selective URAT1 inhibitors. Phase III clinical studies have demonstrated that Urece treatment led to a 100% proportion of patients achieving blood uric acid levels of 6mg or lower at 58 weeks. Additionally, long-term use of the drug has shown no significant impact on renal function and no clinically relevant effect on liver function.- Flcube.com
