▎WuXi AppTec Content Team Report

On May 27, Eisai and Biogen announced that the Korean Ministry of Food and Drug Safety (MFDS) had approvedHumanized Anti-Soluble β-Amyloid (Aβ) Monoclonal AntibodyLecanemab (Chinese generic name: Luncanemab) launched for the treatment ofAdult patients with early (mild) Alzheimer's disease or mild cognitive impairment caused by Alzheimer's diseaseAccording to the Eisai press release, this follows the United States, Japan, and China.lecanemabApproved for marketing in the fourth country.

Alzheimer's disease (AD) is a progressive and irreversible neurodegenerative brain disorder that leads to intellectual disabilities, psychiatric symptoms, and the loss of social and life functions, severely impacting cognitive abilities and normal daily living. It is estimated that in 2021, there were approximately 900,000 dementia patients in South Korea, with one in ten people over the age of 65 affected by dementia and one in five experiencing mild cognitive impairment (MCI).[2]。

LecanemabIt can selectively bind to soluble Aβ polymers (protofibrils) as well as to insoluble Aβ polymers (fibrils), which are the main components of Aβ plaques, therebyClear Aβ fibrils and Aβ plaques in the brain. Through this mechanism of action,lecanemabCan slow disease progression and reduce the rate of cognitive and functional decline.。

According to publicly available information from Eisai,lecanemabHas achieved the primary endpoint and all key secondary endpoints in the global large-scale Phase 3 Clarity AD study, with results that are statistically significant. The results of the Clarity AD study have been published in The New England Journal of Medicine. The study data shows,lecanemabDemonstrated significant efficacy and good safety,Three months of medication significantly reduced Aβ load, effectively slowed disease progression by 27% at 18 months; 60% of earlier-stage patients achieved disease reversal.The study results demonstrateLecanemabHelp early AD patients improve cognitive impairment, maintain independent living for a longer time, thereby reducing the economic burden on families and society.

Meanwhile, Eisai has recently started a rolling submission to the U.S. FDA forWeekly maintenance dosingLecanemab-irmbSubcutaneous InjectionThe BLA (Biologics License Application) was previously granted Fast Track designation by the FDA. If approved by the FDA, this subcutaneous injection can be administered at home or in a medical setting, with a shorter injection process compared to intravenous infusion. In March this year, Eisai also submitted lecanemab to the FDA.Monthly Intravenous (IV) Maintenance DoseThe supplemental Biologics License Application (sBLA).

[1] “LEQEMBI®” (Lecanemab) Approved for the Treatment of Alzheimer’s Disease in South Korea. Retrieved May 27, 2024, from https://www.eisai.com/news/2024/news202436.html

[2]Korean dementia observatory 2022: National Institute of Dementia (Korean)

[3] Lecanemab Approved in China for the Treatment of Alzheimer's Disease. Retrieved Jan 9, 2024, from https://mp.weixin.qq.com/s/YxN-T5s_NhAx1j-loxbtZw