NDA for Luye Pharma's Rivastigmine Twice Weekly Transdermal Patch Filed in Japan for Treating Alzheimer's Dementia

TOKYO, June 6, 2024 /PRNewswire/ -- 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 cases^[1]. 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 2023^[2]. 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 disease^[3].

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 adherence^[4]. 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. 

About Luye Pharma Group

Luye Pharma Group is an international pharmaceutical company dedicated to the R&D, manufacturing and sale of innovative medications. The company has established R&D centers in China, the U.S. and Europe, with a robust pipeline of over 30 drug candidates in China and more than 10 drug candidates in other international markets. Luye Pharma maintains high-level international standards in novel drug delivery technologies including microspheres, liposomes, and transdermal drug delivery systems. The company has also achieved multiple innovations in new chemical entities and antibodies, and is actively making strategic developments in the fields of cell therapies and gene therapies.

Luye Pharma is developing a global supply chain of 8 manufacturing sites built up around the world, with GMP quality management and control systems established in line with international standards. With more than 30 products covering the central nervous system, oncology, cardiovascular, metabolism and other therapeutic areas, business is conducted in over 80 countries and regions around the world, including the largest pharmaceutical markets - China, the U.S., Europe and Japan, as well as in fast growing emerging markets.