Eisai launches Alzheimer’s treatment Leqembi in Korea

Eisai Korea announced Thursday the launch of its Alzheimer’s treatment, Leqembi (lecanemab) injection, in Korea. The drug, approved by the Ministry of Food and Drug Safety (MFDS) in May, is indicated for adults with mild cognitive impairment due to Alzheimer's disease (AD) or mild AD dementia (early AD).

Leqembi targets amyloid beta (Aβ), a key substance linked to AD. It binds to both soluble protofibrils and insoluble fibrils of amyloid beta, reducing plaques in the brain and slowing disease progression. 

The global phase 3 Clarity AD clinical trial demonstrated that Leqembi reduced the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score by 0.45 points compared to a placebo at 18 months, delaying AD progression by 27 percent (95% CI -0.67, -0.23; P<0.001). An open-label extension (OLE) study also showed a 0.95-point reduction in the CDR-SB score after three years of treatment, compared to estimated natural decline.  

In Korea, an estimated 900,000 people aged 65 and older have dementia, with AD accounting for 70 percent of cases. The average annual management cost per dementia patient is 21.1 million won ($15,000), rising to 33.1 million won for severe cases.  

“AD has placed an immense burden on patients and families, with unmet medical needs persisting in the absence of treatments targeting its root causes,” said Ko Hong-byung, CEO of Eisai Korea. “The introduction of Leqembi allows for intervention from the mild cognitive impairment stage."

Eisai Korea is also pursuing regulatory approval for a Leqembi subcutaneous autoinjector, which was submitted to the FDA on Nov. 1. If approved, the device would enable weekly self-administration, reducing injection time from one hour to approximately 15 seconds.

In Europe, Leqembi recently received a positive recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for the treatment of mild cognitive impairment or mild dementia in adults with confirmed amyloid beta pathology who are either non-carriers or heterozygous carriers of the Apolipoprotein E.