TOKYO - Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, 'Biogen') announced today that the results of a detailed analysis of the Phase 3 Clarity AD study demonstrated that lecanemab-irmb (generic name, U.S. brand name: LEQEMBI) treatment showed reductions in amyloid-beta (A) pathology and downstream biomarker changes.

This analysis, and the latest findings on the lecanemab subcutaneous (SC) formulation currently under development, were presented at the Alzheimer's Association International Conference (AAIC) 2023. The U.S. Food and Drug Administration (FDA) granted traditional approval for LEQEMBI for the treatment of Alzheimer's disease (AD) on July 6, 2023.

Clarity AD was a global confirmatory Phase 3 placebo-controlled, double-blind, parallel-group, randomized study in 1,795 people with early AD (lecanemab group: 10 mg/kg bi-weekly IV treatment: 898, placebo group: 897). Lecanemab met the primary endpoint (change from baseline at 18 months on the global cognitive and functional scale, Clinical Dementia Rating-Sum of Boxes [CDR-SB]) and all key secondary endpoints with statistically significant results. In November 2022, results of the Clarity AD study were presented at the Clinical Trials on Alzheimer's Disease (CTAD) conference and simultaneously published in the peer-reviewed medical journal, The New England Journal of Medicine.

Lecanemab: Amyloid Reduction and Evidence of Downstream Biomarker Modification

In addition to the key secondary endpoint of lecanemab's effect on amyloid accumulation in the brain as measured by amyloid positron emission tomography (PET), the Clarity AD study also measured multiple A/T/N+ (amyloid, tau, neurodegeneration) biomarkers involved in the pathophysiology of AD, such as amyloid (A1-42 in CSF, A42/40 ratio in plasma), tau (p-Tau181 in cerebral spinal fluid [CSF] and plasma), neurodegeneration (total tau [t-tau] in CSF and neurofilament light [NfL] in CSF and plasma), astrocyte activation (plasma GFAP: glial fibrillary acidic protein) and synaptic dysfunction (neurogranin in CSF).

An increase in plasma A42/40 ratio was observed with lecanemab compared to placebo (adjusted mean change from baseline of lecanemab: 0.008, placebo: 0.001, p

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