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, /PRNewswire/ -- Luye Pharma Group today announced that marketing approval for its innovative formulation Rivastigmine Twice Weekly Transdermal Patch has been granted by the Japanese Ministry of Health, Labour and Welfare as a new drug, indicated for suppression of progression of dementia symptoms in mild to moderate Alzheimer's disease. The product is to be marketed as Rivaluen® LA Patch 25.92mg/51.84mg. It is the first extended-release Rivastigmine transdermal formulation approved for marketing in the country.
Developed by Luye Pharma on its proprietary platform for transdermal patches, Rivaluen® LA Patch 25.92mg/51.84mg employs an innovative drug delivery system to release the active ingredient, rivastigmine, transdermally twice a week. This approval is based on the positive results of a Phase Ⅲ clinical trial conducted in Japan for patients with Alzheimer's type dementia 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 statistics, there are over 55 million people living with dementia worldwide[2], and that number is over 5 million in Japan. The lifetime risk of dementia in the Japanese elderly population is over 50%, and more than half of all dementia cases are caused by Alzheimer's disease[3].
One of the early symptoms of Alzheimer's type dementia is said to be a decline in the ability to manage medication, and the choice of orally disintegrating tablets or patches has been suggested as a way to improve adherence[4]. Rivastigmine Twice Weekly Transdermal Patch requires a lower application frequency than the once-daily Rivastigmine patches generally available on the market, thereby enabling improved medication adherence among patients. Due to its transdermal route of administration, Rivastigmine Twice Weekly Transdermal Patch is convenient for patients who have difficulty swallowing, and may have the potential to lower the incidence of gastrointestinal adverse reactions such as nausea and vomiting when compared with the oral form of the drug.
To expedite the availability of this innovative treatment for Japanese patients, Luye Pharma entered into an agreement with Towa Pharmaceutical Co., Ltd. (Towa) in December 2020, granting the latter an exclusive license for the development and commercialization of Rivastigmine Twice Weekly Transdermal Patch in Japan. Established in 1951, Towa is a prominent pharmaceutical company in Japan with multiple products in the central nervous system therapeutic area in addition to strong commercial capabilities and a robust operational system in the local market. Luye Pharma looks forward to maintaining close collaboration with Towa to deliver high-quality, innovative drugs as well as services and technologies to those in need.
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In addition to Japan, Rivastigmine Twice Weekly Transdermal Patch has been approved for marketing in multiple European countries and China. Furthermore, Luye Pharma is also registering the product with local partners in selected countries of Southeast Asia and Latin America.
Product Overview of the Rivastigmine Twice Weekly Transdermal Patch for the Japanese Market
| Product name | RIVALUEN® LA Patch 25.92 mg
RIVALUEN® LA Patch 51.84 mg |
| Nonproprietary name | Rivastigmine |
| Indication or efficacy | Suppression of progression of dementia symptoms in mild to moderate Alzheimer's disease |
| Dosage and administration | In general, for adults, administer 25.92 mg of Rivastigmine as a starting dose. Increase to 51.84 mg as a maintenance dose four weeks later in principle.
Apply the patch to normal healthy skin on the back, upper arm, or chest. In principle, apply a patch for four days at start and replace the patch every three or four days (twice weekly). |
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 20 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 achieved multiple innovations in new chemical entities and antibodies, and is also 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.
