Celltrion Applies for MFDS Approval of Donepezil Patch for Dementia Treatment

World's First Alzheimer's Treatment Patch Approved by MFDS... Targeting Commercialization Next Year

[Asia Economy Reporter Kim Ji-hee] Celltrion announced on the 13th that it has applied for marketing approval of 'Donerion Patch,' a donepezil patch for the treatment of Alzheimer's dementia, jointly developed with iCure, to the Ministry of Food and Drug Safety. In 2017, Celltrion signed a domestic co-marketing agreement for the donepezil patch developed by iCure, which had completed preclinical and Phase 1 clinical trials. Since then, together with iCure, they have been conducting Phase 3 clinical trials involving about 400 patients with mild to moderate dementia in four countries: South Korea, Taiwan, Australia, and Malaysia.

The Phase 3 clinical trial was conducted over a total of 24 weeks. The participants were divided into groups currently taking oral donepezil 5 mg or 10 mg and groups who had never taken donepezil, and were administered either oral donepezil or Donerion Patch.

First, the Alzheimer's dementia patients with mild to moderate symptoms were evaluated using the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog), a representative standard tool that assesses memory, language, reconstruction, and behavior, as the primary efficacy endpoint. Through this, the non-inferiority of Donerion Patch compared to oral donepezil was demonstrated. Additionally, to comprehensively evaluate the drug's effects in terms of cognitive and functional improvement, secondary efficacy endpoints (CIBIC-plus, MMSE, CDR-SB, NPI) were set, confirming the non-inferiority of Donerion Patch compared to oral donepezil.

Donerion Patch is a reformulated new drug developed as a formulation applied twice a week, compared to once-daily oral donepezil. It improves medication adherence and convenience compared to oral formulations. If approved by the Ministry of Food and Drug Safety, it will become the world's first donepezil patch. The two companies aim to commercialize it next year after obtaining marketing approval.

Donepezil is the most prescribed ingredient among Alzheimer's dementia treatments. According to the pharmaceutical market research firm Ubist, donepezil accounted for about 80% of the approximately 290 billion KRW domestic sales of Alzheimer's dementia treatments last year, amounting to about 230 billion KRW.

A Celltrion official said, "As Donerion Patch is developed as the world's first donepezil patch, it is expected to enter the market quickly with differentiated competitiveness from existing formulations by improving patient convenience once approved by the Ministry of Food and Drug Safety. In response to the aging society, we will do our best to commercialize the donepezil patch to provide various treatment options for dementia patients in Korea."

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