BioArctic AB’s (publ) associate, Eisai, has rolled out Leqembi (generic name: lecanemab) in South Korea. This comes after the medication was greenlit in May 2024, for adults exhibiting mild cognitive impairment due to Alzheimer’s disease (AD) or early-stage AD dementia.
With around 900,000 dementia diagnoses in South Korea as of 2021, where one-tenth of individuals aged over 65 are affected by dementia and one-fifth by mild cognitive impairment (MCI), Alzheimer’s disease makes up approximately 70% of such cases. Initially, Eisai plans to introduce Leqembi within the private healthcare sector.
Leqembi targets both soluble amyloid-beta (Aß) aggregates known as protofibrils and insoluble aggregates or fibrils, the principal elements of Aß plaques found in AD. Through this action, Leqembi effectively diminishes both Aß protofibrils and plaques in the brain, marking the first authorized treatment that attenuates disease progression and mitigates cognitive and functional deterioration.
The fruition of BioArctic’s collaboration with Eisai, Leqembi, was initially developed by BioArctic based on research conducted by Professor Lars Lannfelt and his findings on the Arctic mutation in Alzheimer’s disease. While Eisai spearheads the clinical development, market approval applications, and the commercialization of lecanemab for Alzheimer’s, BioArctic retains co-commercialization rights in the Nordic regions, pending European market authorization. Together, they are gearing up for commercialization in this locality.
Lecanemab, a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody, is designed to target aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aß), a result of BioArctic and Eisai’s strategic research endeavors.
Globally, lecanemab holds approvals as a therapy for MCI associated with AD and mild AD dementia in regions including the US, Japan, China, South Korea, Hong Kong, Israel, the UAE, and Great Britain. These endorsements, complemented by the CHMP’s favorable opinion, stem predominantly from Eisai’s Clarity AD clinical trial— a phase 3 investigation that fulfilled its primary and key secondary endpoints with statistically significant outcomes. Predominant side effects in the lecanemab cohort (>10%) include infusion reactions, ARIA-H (involving small and large cerebral hemorrhages, and superficial siderosis), ARIA-E (edema/effusion), headache, and falls.
Eisai has pursued regulatory permissions for lecanemab across 17 additional regions, including the European Union. In November 2024, the CHMP issued a favorable review, authorizing the medication. Meanwhile, a sBLA for a less frequent intravenous maintenance dosing was filed with the US FDA in March 2024, with acceptance following in June 2024. October the same year saw the completion of the BLA for a subcutaneous injection maintenance dose submission in the US, recognized with Fast Track status.
Since July 2020, Eisai’s Phase 3 AHEAD 3-45 trial, investigating lecanemab for individuals with preclinical AD (those showing intermediate or elevated amyloid levels but clinically normal), is progressing with full recruitment achieved by October 2024. A public-private collaboration underpins this four-year project, facilitated by the Alzheimer’s Clinical Trial Consortium and funded by the National Institute on Aging and Eisai. As of January 2022, the Tau NexGen clinical investigation for Dominantly Inherited AD (DIAD), undertaken by Washington University School of Medicine, includes lecanemab as the primary anti-amyloid treatment.
Since 2005, a long-term partnership between BioArctic and Eisai has focused on AD drug development and commercialization. Key agreements encompass the 2007 lecanemab development and marketing pact and the 2015 back-up antibody agreement for Alzheimer’s treatment. Also, Eisai joined forces with Biogen in 2014 to jointly advance and market lecanemab. While Eisai handles development, market approval, and commercialization, BioArctic is entitled to royalties from global sales and milestone payments, bearing no developmental costs for lecanemab in Alzheimer’s.
Headquartered in Sweden, BioArctic AB (publ) stands out as a research-driven bio-pharmaceutical entity dedicated to pioneering therapeutics that aim to stall or completely arrest the advancement of neurodegenerative ailments.