Luye Pharma Submits NDA in Japan for Twice Weekly Rivastigmine Patch for Alzheimer's Treatment
Friday, June 07, 2024
Luye Pharma Group has announced that Towa Pharmaceutical Co., Ltd. (Towa) has filed a New Drug Application (NDA) with Japan's Ministry of Health, Labour and Welfare (MHLW) for the Rivastigmine Twice Weekly Transdermal Patch, designed for treating mild to moderate dementia associated with Alzheimer’s disease.
This drug, developed using Luye Pharma's proprietary transdermal patch platform, utilizes an innovative delivery system to administer rivastigmine transdermally twice a week. In December 2020, Luye Pharma granted Towa an exclusive license for the development and commercialization of this drug in Japan.
Towa's NDA submission is based on interim results from a Phase 3 clinical trial in Japan, which met the primary efficacy endpoint for patients with Alzheimer’s-related dementia.
Alzheimer's disease, a neurodegenerative condition that leads to progressive cognitive decline, is the most common form of dementia, accounting for 50%-75% of all cases. As of 2023, 29.1% of Japan’s 125 million population was aged 65 or older, according to the Ministry of Internal Affairs and Communications. Studies show that more than 50% of the elderly in Japan have a lifetime risk of developing dementia, with over half of these cases being Alzheimer’s disease.
Since managing medication can be an early challenge for those with Alzheimer’s, orally disintegrating tablets and patches have been suggested to improve adherence. The Rivastigmine Twice Weekly Transdermal Patch, which requires less frequent administration than the typical once-daily patches, aims to enhance medication adherence.
Kiyoshi Kaneko, President of Luye Life Sciences Japan and head of Luye Pharma Japan, stated: “There is a significant unmet need for effective treatments for dementia associated with Alzheimer’s disease in Japan. Difficulties in medication management and adherence can negatively impact treatment outcomes and place a heavy burden on families and healthcare systems. We are hopeful for the approval of this easy-to-use, innovative product to help improve the quality of life for patients and caregivers in Japan.”
Luye Pharma is working on the global development and commercialization of the Rivastigmine Twice Weekly Transdermal Patch. It has been approved for marketing in several European countries and China, and is also being registered or developed in partnership with various countries in Southeast Asia and Latin America for future commercialization.
Source: luye.cn
