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“URECE® TABLETS” (DOTINURAD) APPROVED IN THAILAND FOR GOUT AND HYPERURICEMIA

ý. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has received approval for “URECE® Tablets” (dotinurad) in Thailand as a treatment for gout and hyperuricemia. This approval is the first time that the agent has been approved in China or the five ASEAN (Association of Southeast Asian Nations) member states where Eisai holds licenses to develop and distribute the agent.

 

“URECE Tablets” are a new therapeutic medicine for gout and hyperuricemia discovered by FUJI YAKUHIN. It suppresses uric acid reabsorption and lowers blood uric acid levels by selectively inhibiting the urate transporter (URAT1) related to reabsorption of uric acid in the kidney. Eisai concluded a license agreement with FUJI YAKUHIN in February 2020 for China and in August 2021 for five ASEAN member states: Indonesia, Malaysia, Myanmar, the Philippines, and Thailand, granting exclusive development and distribution rights in these countries.

 

Hyperuricemia is known to be associated with various diseases, including those of the urinary system, endocrine system, metabolic system, and cardio-cerebrovascular system, as well as gout. Furthermore, the prevalence of hyperuricemia in Thailand is estimated to be as high as 10.6%.1 It is expected that the number of patients will further increase in the near future due to changes in lifestyle and dietary preferences in accordance with socioeconomic development.

 

Eisai is committed to providing new treatment options for gout and hyperuricemia in China and the applicable ASEAN member states, and will further contribute to improving the quality of life (QOL) of patients.

 

 

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<Notes to editors>

ý “URECE® Tablets” (Dotinurad)

URECE Tablets are a therapeutic medicine for gout and hyperuricemia discovered by FUJI YAKUHIN. URECE Tablets selectively inhibit URAT1, one of the uric acid transporters, thus preventing reabsorption of uric acid by the kidneys and promoting uric acid excretion in the urine. In addition, it has a small effect on other transporters affecting uric acid secretion, so it reduces serum uric acid levels at lower doses. URECE Tablets are expected to have a low risk of side effects and drug interaction.

In Japan, FUJI YAKUHIN obtained manufacturing and marketing approval for dotinurad in January 2020 and launched it in May 2020.

 

1. Lohsoonthorn, V. et al. Relationship with Metabolic Syndrome in Thai Adults Receiving Annual Health Exams Archives of Medical Research 37, p 883-889 (2006). https://www.sciencedirect.com/science/article/pii/S0188440906001482?via%3Dihub