Eisai Co., Ltd. and KYORIN Pharmaceutical Co., Ltd. announced that Eisai (Thailand) Marketing Co., Ltd. has launched Beova® Tablets (generic name vibegron) for overactive bladder treatment in Thailand, representing the first market entry within Eisai's licensed ASEAN region.
The launch follows Eisai's acquisition of exclusive development and marketing rights from KYORIN in 2021 for Thailand, the Philippines, Malaysia, and Brunei. Eisai Thailand submitted the marketing authorization application in March 2023 and received approval in June 2024.
Addressing Significant Medical Need
Overactive bladder (OAB) is a urological condition characterized by trouble pooling urine in the bladder, with the predominant symptom being an urge to urinate. The condition is often accompanied by frequent urination and nocturia, and in some cases by urge urinary incontinence.
The prevalence of OAB in Thailand is reported to be 15.8%, according to data presented at ICS2024. The condition significantly impacts patients' quality of life, as individuals often refrain from leaving the house due to anxiety about bathroom access, experience sleep disruption at night, and face limitations in daily activities.
OAB increases with age but has also been reported to be caused by brain or spinal cord disorders such as cerebrovascular diseases (cerebral hemorrhage and cerebral infarction), Parkinson's disease, and benign prostatic hyperplasia.
Mechanism of Action
Beova is a selective β3-adrenergic receptor agonist administered once daily. The medication acts selectively on β3 receptors in the bladder, relaxing the bladder to enhance urine collection and consequently improving symptoms of urgency, urinary frequency, and urge urinary incontinence associated with OAB.
Vibegron was originally discovered by Merck & Co., Rahway, N.J., U.S.A. as a once-daily oral treatment for overactive bladder. The drug selectively acts on β3 receptors in the bladder and increases bladder capacity by enhancing the bladder-relaxing effect of noradrenaline during the urinary storage phase.
Expanding Treatment Portfolio
The launch of Beova complements Eisai's existing overactive bladder treatment portfolio in the region. Since September 2009, KYORIN and Eisai have maintained a license agreement for the development and marketing in Asia of Uritos® Tablets (generic name: imidafenacin), another therapeutic agent for overactive bladder discovered and developed by KYORIN. Eisai currently sells Uritos in Thailand, the Philippines, Indonesia, Cambodia, Vietnam, Laos, and Myanmar.
Regional Expansion Plans
Beyond Thailand, approvals have been obtained in the Philippines and Malaysia, with preparations underway for market entry in these territories. In Japan, KYORIN and Kissei have jointly developed the agent under a co-development and co-marketing agreement established in March 2016, marketing it as "Beova® Tablets 50mg" since November 2018.
KYORIN obtained exclusive rights for developing, manufacturing, and marketing vibegron in Japan (July 2014) and Asia (April 2017) from Merck & Co., Inc. The Asian territories include South Korea, Taiwan, Hong Kong, and 10 member states of ASEAN.
The launch represents Eisai's continued commitment to providing new treatment options for OAB patients and contributing to improved quality of life for individuals with overactive bladder across Asia.