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.

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. 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. 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.

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.