The Japanese Ministry of Health, Labour and Welfare has granted marketing approval for Luye Pharma Group's Rivastigmine Twice Weekly Transdermal Patch for the treatment of mild to moderate Alzheimer's disease. The product, to be marketed as Rivaluen® LA Patch 25.92mg/51.84mg, represents the first extended-release rivastigmine transdermal formulation approved in Japan.
The approval follows successful Phase III clinical trials in Japanese patients with Alzheimer's type dementia, which met the primary efficacy endpoint. The innovative formulation is designed to suppress the progression of dementia symptoms by delivering the active ingredient, rivastigmine, through the skin twice weekly rather than daily.
Addressing a Significant Public Health Challenge
Alzheimer's disease, a progressive neurodegenerative condition affecting memory and cognition, accounts for 50-75% of all dementia cases globally. In Japan, where the elderly population faces a lifetime dementia risk exceeding 50%, more than 5 million people currently live with the condition. Worldwide, dementia affects over 55 million individuals, with Alzheimer's disease representing the majority of cases.
"The approval of this innovative formulation addresses a critical need in Alzheimer's care," said a representative from the Japanese Ministry of Health, Labour and Welfare. "Medication adherence is a significant challenge in this patient population, and simplified dosing regimens can make a meaningful difference."
Innovative Delivery System Offers Patient Benefits
Developed on Luye Pharma's proprietary transdermal patch platform, the twice-weekly application schedule offers significant advantages over conventional once-daily patches. This reduced frequency may particularly benefit Alzheimer's patients, who often experience declining ability to manage medications as an early symptom of the disease.
The transdermal route of administration provides additional benefits for patients with swallowing difficulties, a common issue in the elderly population. Clinical data suggests the patch formulation may also reduce gastrointestinal adverse reactions such as nausea and vomiting compared to oral rivastigmine.
Dr. Hiroshi Tanaka, a neurologist at Tokyo Medical University who participated in the clinical trials, noted, "Many of my patients struggle with daily medication regimens. A twice-weekly patch represents a meaningful advance that could improve treatment adherence and potentially lead to better outcomes."
Commercial Partnership and Global Expansion
To accelerate the availability of this treatment for Japanese patients, Luye Pharma partnered with Towa Pharmaceutical Co., Ltd. in December 2020. The agreement grants Towa exclusive rights for development and commercialization in Japan. Established in 1951, Towa brings extensive experience in central nervous system therapeutics and strong commercial capabilities in the Japanese market.
"Our partnership with Towa Pharmaceutical allows us to leverage their established presence in Japan's CNS market," said a spokesperson for Luye Pharma. "This collaboration ensures Japanese patients will have timely access to this innovative treatment option."
Beyond Japan, the Rivastigmine Twice Weekly Transdermal Patch has already received marketing approval in multiple European countries and China. Luye Pharma is actively pursuing registration with local partners in selected countries throughout Southeast Asia and Latin America, reflecting the company's global expansion strategy.
Advancing Alzheimer's Treatment Options
The approval comes at a critical time as Japan faces a rapidly aging population. With more than a quarter of Japanese citizens over age 65, the burden of Alzheimer's disease and other dementias continues to grow, placing increasing pressure on healthcare systems and caregivers.
Current treatment options for Alzheimer's disease primarily focus on symptom management rather than disease modification. Cholinesterase inhibitors like rivastigmine represent a cornerstone of therapy, particularly in mild to moderate disease stages, by increasing acetylcholine levels in the brain to compensate for the loss of functioning brain cells.
The twice-weekly patch formulation joins Luye Pharma's growing portfolio of central nervous system treatments. The company has established research and development centers in China, the United States, and Europe, with a robust pipeline spanning multiple therapeutic areas including CNS disorders, oncology, cardiovascular disease, and metabolic conditions.
Market Impact and Future Directions
Analysts project the new formulation could capture a significant share of Japan's Alzheimer's treatment market, estimated at approximately $1.2 billion annually. The convenience of twice-weekly application may drive patient preference and physician adoption, particularly for community-dwelling patients who rely on caregivers for medication management.
As the global population ages, innovative drug delivery systems that improve adherence and quality of life for patients with chronic neurological conditions will likely play an increasingly important role in healthcare strategies. Luye Pharma's continued investment in transdermal drug delivery technologies positions the company to address these evolving needs.
With manufacturing capabilities spanning eight sites globally and operations in over 80 countries and regions, Luye Pharma continues to expand its international footprint while maintaining GMP quality management systems aligned with international standards.
