Lecanemab

Accelerated approval, despite recent controversies, has historically provided therapeutic momentum, particularly in HIV and cancer treatments. Key issues include reliance on surrogate endpoints and confirmatory trial failures, yet the pathway has led to significant drug approvals, offering hope for diseases with high unmet needs.

Eisai launched Leqembi in South Korea for mild cognitive impairment due to Alzheimer’s disease or mild AD dementia. Leqembi selectively binds to amyloid-beta aggregates, reducing disease progression and cognitive decline. Developed by BioArctic and Eisai, it is approved in multiple countries and under review in others. BioArctic and Eisai are preparing for joint commercialization in the Nordic region.

Eisai Korea launches Alzheimer’s treatment Leqembi (lecanemab) injection in Korea, targeting amyloid beta to reduce plaques and slow disease progression. The drug showed significant efficacy in clinical trials, delaying AD progression by 27 percent. Eisai Korea also seeks approval for a Leqembi subcutaneous autoinjector for easier administration.

Eisai and Biogen launch LEQEMBI, a humanized anti-amyloid-beta monoclonal antibody, in South Korea for treating Alzheimer's disease, targeting soluble and insoluble Abeta aggregates to reduce cognitive decline.

Eisai and Biogen launch Leqembi in South Korea for mild cognitive impairment or early Alzheimer’s disease.

Eisai launches Leqembi in South Korea for mild cognitive impairment due to Alzheimer's disease. Leqembi selectively binds to amyloid-beta aggregates, reducing disease progression and cognitive decline. Developed by BioArctic and Eisai, it's the first treatment to show efficacy through this mechanism.

Eisai and Biogen launch LEQEMBI, a humanized anti-soluble aggregated amyloid-beta monoclonal antibody, in South Korea for treating mild cognitive impairment due to Alzheimer's disease or mild AD dementia. LEQEMBI selectively binds to soluble and insoluble Aβ aggregates, reducing both protofibrils and plaques in the brain, and is the first treatment shown to slow cognitive and functional decline through this mechanism.

Eisai and Biogen launch LEQEMBI in South Korea, a humanized anti-soluble aggregated amyloid-beta monoclonal antibody for mild cognitive impairment due to Alzheimer's disease or mild AD dementia. LEQEMBI selectively binds to soluble and insoluble Aβ aggregates, reducing both protofibrils and plaques in the brain, and is the first treatment shown to slow cognitive and functional decline.

EMA recommends Leqembi for early Alzheimer's patients without Apoe4 gene, reversing previous stance due to lower ARIA risk. UK's Nice deems it not cost-effective, while Eli Lilly's donanemab and Roche's trontinemab show promise.

EU regulators initially rejected Leqembi, an anti-amyloid drug for Alzheimer's, due to side effects like brain swelling and bleeding. Eisai requested a re-evaluation, leading the EMA to recommend approval for patients with one or zero copies of the ApoE4 gene, where benefits outweigh risks. The decision now awaits finalization by the European Commission.