KUALA LUMPUR, Nov 17 (Bernama) -- Icure Pharmaceutical Inc, a biopharmaceutical company in Korea, announced its donepezil patch, a treatment of Alzheimer’s-type dementia, received a drug product approval from the Ministry of Food and Drug Safety of Korea.
According to a statement, the drug product approval process took seven months after an application was filed in April this year. With the approval, Icure marks the first commercialisation of the donepezil patch in the world.
“Based on outstanding efficacy and marketability of donepezil along with our technological prowess, we expect our donepezil patch will sufficiently take over the market of donepezil oral products as we have seen a high conversion rate of rivastigmine patches in the past,” said Icure Chief Executive Officer, YoungKweon Choi, Ph.D. who led donepezil patch development.
Donepezil is a current typical treatment that has been widely prescribed for the longest period for Alzheimer’s disease patients in severity ranging from mild to moderate and severe ones among FDA-approved Alzheimer's treatments.
Due to difficulty in the development of its formulations, donepezil has been commercialised for only oral administration to date.
With successful completion of a Phase III clinical trial for the first time in the world, the donepezil patch of Icure is expected to significantly improve the quality of life of patients with Alzheimer’s-type dementia and their caregivers by enhancing the convenience in its use from orally taking once daily to putting a patch on skin twice a week.
With nearly 400 mild and moderate dementia patients in Korea, Taiwan, Australia and Malaysia, Icure successfully conducted a Phase III clinical study for its donepezil patch.
Specifically, the study demonstrated noninferiority compared to oral donepezil in Alzheimer's disease assessment scale cognitive subscale (ADAS-cog), a typical standard tool for evaluating abilities of memory, language, reorganisation, action and orientation in patients with mild and moderate Alzheimer’s-type dementia.
Now that its donepezil patch received FDA approval for Phase I clinical trial as an investigational new drug in April, Icure will start to administer it to patients in the latter part of 2022.
More details at https://icure.co.kr.
-- BERNAMA
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