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news.BioArctic's partner Eisai has announced that Leqembi, has received approval in Israel for the treatment of Alzheimer's disease (AD), specifically for patients with mild cognitive impairment or mild dementia, the same stages targeted in clinical trials.
Israel becomes the sixth territory to endorse the drug for Alzheimer's treatment after the US, Japan, China, South Korea, and Hong Kong. Credit: TioNegro14 from Pixabay.
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The approval of Leqembi (generic name: Lecanemab) in Israel marks a significant milestone, as Israel becomes the sixth territory to endorse the drug for Alzheimer’s treatment after the US, Japan, China, South Korea, and Hong Kong.
This approval is a testament to the drug’s potential in altering the progression of the disease.
The approval of Leqembi in Israel is based on the results of the global Phase III Clarity AD study, where the drug met its primary endpoint and all key secondary endpoints with statistically significant outcomes.
Leqembi’s effectiveness in reducing the rate of disease progression and slowing cognitive and functional decline has positioned it as the world’s first approved treatment with this mechanism of action.
Selectively Leqembi binds to soluble amyloid-beta (Aβ) aggregates (protofibrils), as well as insoluble Aβ aggregates (fibrils) which are a significant aspect of Aβ plaques in AD, thereby lowering both Aβ protofibrils and Aβ plaques in the brain.
The development of Leqembi is the fruit of a longstanding collaboration between BioArctic and Eisai, with the antibody originally developed by BioArctic based on the work of Professor Lars Lannfelt, who discovered the Arctic mutation in Alzheimer’s disease.
While Eisai handles the clinical development, market approval applications, and commercialization of Lecanemab for Alzheimer’s disease, BioArctic remains free from development costs and is entitled to a 9% royalty on global sales, alongside payments for certain regulatory approvals and sales milestones.
Furthermore, BioArctic retains the right to commercialise Leqembi in the Nordic region, subject to European approval.
Currently, Eisai and BioArctic are jointly preparing for the drug’s commercialisation in these markets.
