Eisai receives approval for URECE tablets in Thailand, expands operations in Saudi Arabia

JAPAN—Eisai Co., Ltd., a leading pharmaceutical company based in Japan, has announced that it has received approval to market “URECE® Tablets” (dotinurad) in Thailand.

The tablets, a novel treatment for gout and hyperuricemia, were initially developed by FUJI YAKUHIN and were first approved for use in Japan in January 2020, with sales commencing in May 2020.

This latest approval marks a significant milestone for Eisai, as it is the first authorization for dotinurad in any of the ASEAN (Association of Southeast Asian Nations) member states or China, where Eisai holds exclusive licenses for its development and distribution.

FUJI YAKUHIN originally developed URECE Tablets to suppress uric acid reabsorption and reduce elevated uric acid levels by selectively inhibiting the kidneys’ urate transporter (URAT1).

Under a licensing agreement signed with FUJI YAKUHIN, Eisai was granted exclusive development and distribution rights for dotinurad in China in February 2020.

This was followed by an agreement in August 2021 that included five ASEAN countries: Indonesia, Malaysia, Myanmar, the Philippines, and Thailand.

The approval of URECE Tablets in Thailand is particularly timely given that hyperuricemia, often associated with various health conditions such as gout and diseases of the urinary, endocrine, metabolic, and cardiovascular systems, affects an estimated 10.6% of the Thai population.

This prevalence is expected to rise due to shifts in lifestyle and dietary habits driven by socioeconomic growth in the region.

Eisai has committed to enhance the treatment landscape for gout and hyperuricemia in China and the ASEAN region, where the need for effective therapeutic options is growing.

By introducing URECE Tablets, the company aims to improve the quality of life (QOL) for patients suffering from these conditions.

Eisai establishes new subsidiary in Saudi Arabia

In addition to the developments in Thailand, Eisai Co. also announced that full-scale operations have begun at its newly established pharmaceutical sales subsidiary in Saudi Arabia—Eisai Pharmaceuticals Single Person Limited Liability Company (Eisai Saudi Arabia).

This Riyadh-based subsidiary is fully owned by Eisai Europe, the company’s European regional headquarters, and reflects Eisai’s long-standing presence in the Middle East, dating back to the 1960s.

Initially, Eisai operated in the region by marketing and selling its products through local distribution partners.

In Saudi Arabia, Eisai first introduced Methycobal, a treatment for peripheral neuropathy, in 2009, followed by the launch of the antiepileptic drug Fycompa in 2018 and the anticancer treatment Lenvima in 2020.

Eisai Saudi Arabia was officially established in April 2024 to enhance its operations further to create an in-house sales system.

The company is now in the process of assuming full commercial rights for its products from local distributors.

As of October 2024, Eisai Saudi Arabia has taken over sales and marketing activities for Methycobal and Fycompa and plans to expand these efforts to include Lenvima and the anticancer agent Halaven by April 2025.

Moreover, the company has submitted an application for lecanemab, an Alzheimer’s disease treatment, which is currently under review by Saudi health authorities. 

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