Reuters. 2023. Japan approves Alzheimer's treatment Leqembi by Eisai and Biogen. Last accessed: October 2024. The Pharma Letter. 2024. Brief - Alzheimer drug Leqembi now approved in China. Last accessed: October 2024. Pharmaceutical Technology. 2024. South Korea's MFDS approves Eisai-Biogen's LEQEMBI for Alzheimer's. Last accessed: October 2024.

LEQEMBI is indicated for the treatment of Alzheimer’s disease (AD) in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD). A Prescription Drug User Fee Act (PDUFA) action date is set for August 31, 2025.

Jul 11, 2024 · LEQEMBI is the first approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline through this mechanism. LEQEMBI has also been approved in the U.S., Japan, China, South Korea and Hong Kong, and is being marketed in the U.S. Japan and China.

Leqembi is the first amyloid beta-directed antibody to be converted from an accelerated approval to a traditional approval for the treatment of Alzheimer’s disease. The drug works by...

Jul 30, 2024 · Eisai and Biogen presented LEQEMBI findings from the Clarity AD Phase 3 study, showing significant reductions in cognitive decline and functional improvements.

Jan 6, 2023 · Leqembi is the second of a new category of medications approved for Alzheimer’s disease that target the fundamental pathophysiology of the disease. These medications represent an...

Jan 9, 2024 · LEQEMBI is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). LEQEMBI is an amyloid beta-directed antibody indicated as a disease-modifying treatment for Alzheimer’s disease (AD) in the U.S.

Jul 31, 2024 · Dual-acting lecanemab is the only early AD treatment widely available to support neuronal function by clearing the highly toxic protofibrils that continue to cause neuronal injury and death even after plaques have been cleared from the brain.

Biogen Inc. LEQEMBI is the only FDA-approved anti-amyloid therapy that potentially could offer the convenience of a subcutaneous injection with at-home administration option

Jan 14, 2025 · LEQEMBI is indicated for the treatment of Alzheimer’s disease (AD) in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD). A Prescription Drug User Fee Act (PDUFA) action date is set for August 31, 2025.