June 6, 2024 – Luye Pharma Group announced that its partner Towa Pharmaceutical Co., Ltd. (Towa) has filed a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare (MHLW) in Japan for the Rivastigmine Twice Weekly Transdermal Patch for treating mild to moderate dementia associated with Alzheimer’s disease.
The drug was developed by Luye Pharma on its proprietary transdermal patch platform, utilizing an innovative drug delivery system to administer rivastigmine transdermally twice a week. In December 2020, Luye Pharma entered into an agreement with Towa, granting the latter an exclusive license to develop and commercialize this drug in Japan.
The NDA was filed by Towa based on the interim analysis results of a Phase 3 clinical trial in Japan involving patients with dementia associated with Alzheimer's disease, which met the primary efficacy endpoint.
Alzheimer's disease is a neurodegenerative disease that causes a progressive decline in memory and other aspects of cognition. It is the most common type of dementia, accounting for 50%-75% of all cases1. According to data from Japan’s Ministry of Internal Affairs and Communications, out of the country’s total population of 125 million people, 29.1% were 65 or older in 20232. Additionally, a study shows the lifetime risk of dementia in the Japanese elderly population exceeds 50%, and over 50% of all dementia cases are Alzheimer’s disease3.
For people with Alzheimer’s disease, a decline in the ability to manage medication is said to be one of the early symptoms, and orally disintegrating tablets and patches have been suggested as being able to improve medication adherence4. The Rivastigmine Twice Weekly Transdermal Patch is administered less frequently versus the once-daily rivastigmine patches generally available in the market, helping to maintain better medication adherence.
Kiyoshi Kaneko, President of Luye Life Sciences Japan and head of Luye Pharma Japan, said: “There is a significant unmet need for the treatment of dementia associated with Alzheimer’s disease in Japan. Patients often face challenges in medication management and adherence, which can negatively impact treatment outcomes and place a substantial burden on both families and healthcare systems. We look forward to the early approval of this easy-to-administer, innovative product in Japan, to help improve the quality of life for local patients and their caregivers.”
Luye Pharma is developing and commercializing the Rivastigmine Twice Weekly Transdermal Patch globally. The product has been approved for marketing in multiple European countries and China. In addition to Japan, the product is also being registered or developed with partners in several Southeast Asian and Latin American countries for commercialization.
References:
1. https://www.alzint.org/about/dementia-facts-figures/types-of-dementia/alzheimers-disease/. Accessed on June 6, 2024.
2. Statistics Bureau of Japan. https://www.stat.go.jp/data/topics/topi1380.html. Accessed on June 6, 2024.
3. Takeshi Iwatsubo, et al. Alzheimer’s Disease Research in Japan: A Short History, Current Status and Future Perspectives toward Prevention. The Journal of Alzheimer’s Disease. Volume 8, pages 462–464, (2021)
4. The Japan Geriatrics Society, Japan Agency for Medical Research and Development Research Fund, Research Group on the Safety of Drug Treatment for the Elderly, Guidelines for Safe Drug Therapy for the Elderly 2015
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