On December 10, 2024, Eisai China announced that its novel urate reabsorption inhibitor, Dotinurad Tablets (brand name: Uloric®), had been approved by the National Medical Products Administration (NMPA) in China for the indication of gout with hyperuricemia. Dotinurad has also become the first highly selective URAT1 inhibitor approved in China, marking a milestone development that signifies Chinese gout patients will have a new treatment option.
Clinical trial data show that dotinurad, as an innovative drug, selectively inhibits urate reabsorption and effectively inhibits the uric acid transporter URAT1 in the renal proximal tubule without affecting the function of uric acid excretion factors ABCG2 and OAT1/3, leading to higher efficiency in reducing serum uric acid. It does not inhibit ABCG2 in the intestine, thus not affecting intestinal uric acid excretion, which may reduce the burden on the kidneys. Additionally, it does not increase the accumulation of uremic toxins, potentially helping to lower the risks of CKD and CVD.
In the Phase III study in China, the proportion of patients treated with 4mg Dotinurad for 24 weeks achieving a serum uric acid level of ≤6 mg/dL (360 μmol/L) was 73.6%, significantly higher than the 38.1% observed in the 40mg Febuxostat group. In the Phase III study conducted in Japan, the use of Dotinurad for 58 weeks showed no significant impact on liver and kidney function, with a 100.00% uric acid control rate at 4mg Dotinurad, no dose adjustment required in patients with mild to moderate renal impairment, and no serious cardiovascular adverse reactions were found in multiple clinical studies.
Currently, the prevalence of gout in China is approximately 1% to 3%, and it shows an increasing trend year by year as well as a trend towards younger age groups, but treatment options remain very limited. Gout results from purine metabolism disorders and/or reduced uric acid excretion leading to persistent hyperuricemia, forming monosodium urate crystals that deposit in the body and cause crystal-induced arthropathy. Hyperuricemia is not only the biochemical basis of gout but also an independent risk factor for diabetes, cardiovascular diseases, chronic kidney disease, and stroke, posing a serious threat to human health.
Eisai has been in close collaboration with Fuji Pharmaceuticals, signing exclusive development and sales license agreements for Dotinurad in China and five ASEAN member countries (Indonesia, Malaysia, Myanmar, the Philippines, and Thailand) in February 2020 and August 2021, respectively. The recent approval of Dotinurad in China marks a significant achievement of this partnership. Dotinurad has already been approved for marketing in Japan in 2020 and in Thailand in 2024.
With the approval of Dotinurad in China and its upcoming commercial launch, it is believed to bring new treatment hope to a wide range of gout patients, helping them stay free from gout attacks and enjoy a better life. In the future, Eisai China will continue to uphold "hhc" (human health care, caring for human health)" corporate philosophy, continuously explore and introduce more innovative drugs, enrich the product pipeline, and make greater contributions to improving patients' health and well-being.