Celltrion Receives MFDS Approval for Alzheimer's Dementia Treatment 'Patch'

Incheon Songdo Celltrion Plant 2 Overview. / Incheon - Photo by Hyunmin Kim kimhyun81@

[Asia Economy Reporter Seo So-jeong] Celltrion announced on the 5th that its Donepezil patch for Alzheimer's dementia treatment, 'Donerion Patch,' has received marketing authorization from the Ministry of Food and Drug Safety.

According to Celltrion, this is the world's first case of a patch-type drug containing donepezil to receive marketing authorization from health authorities.

Donerion Patch secured efficacy based on Phase 3 clinical trial results involving approximately 400 patients with mild to moderate dementia in four countries: Korea, Taiwan, Australia, and Malaysia. In particular, it demonstrated non-inferiority to oral donepezil in the ADAS-cog (Alzheimer's Disease Assessment Scale?Cognitive Subscale) evaluation, a representative standard tool that assesses memory, language, reconstruction, behavior, and orientation in patients with mild to moderate Alzheimer's dementia.

Additionally, in a 24-week Phase 3 clinical trial targeting patients with mild to moderate Alzheimer's dementia, Donerion Patch proved non-inferiority in therapeutic effect (ADAS-cog) compared to oral Aricept tablets administered as a control drug. These results statistically confirmed that there was no significant difference in effect when patients who had been taking oral donepezil switched to an equivalent dose of the patch, as well as for patients who were administered the patch from the start.

Until now, donepezil has only been commercialized in oral form due to difficulties in formulation development. Donerion Patch is an improved new drug developed as a type of donepezil patch applied to the skin twice a week, replacing the once-daily oral donepezil. It improves medication adherence and convenience compared to oral drugs.

A Celltrion official stated, "With Donerion Patch securing the status and priority as the world's first donepezil patch, it is expected to exert considerable influence in the Alzheimer's dementia treatment market, which emphasizes medication adherence and convenience as much as drug efficacy. We will expedite the commercialization of the donepezil patch to ensure that Alzheimer's patients and their families can benefit from this new treatment option as soon as possible."

Meanwhile, in August, Celltrion secured exclusive domestic sales rights for about 12 years for Donerion Patch through a contract with iCure. The co-developer iCure will be responsible for the production and supply of the donepezil patch, while Celltrion Pharm plans to handle domestic marketing and distribution.

This content was produced with the assistance of AI translation services.