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UK Approves Leqembi for Early Alzheimer's Treatment
14 Nov, 2025
Summary
- UK approves Leqembi for early Alzheimer's treatment
- Leqembi is a monoclonal antibody targeting amyloid-beta
- Maintenance dosing of 10mg/kg IV every 4 weeks approved
On November 14, 2025, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) approved Leqembi (lecanemab), a humanized anti-soluble aggregated amyloid-beta monoclonal antibody, for the treatment of early Alzheimer's disease. This decision follows the MHRA's previous approval in August 2024 for treating mild cognitive impairment (MCI) and mild dementia caused by Alzheimer's in adults who are apolipoprotein E ε4 non-carriers or heterozygotes.
The latest approval allows patients to transition to a maintenance dosing schedule of 10mg/kg intravenous (IV) infusion every four weeks, after an initial 18-month regimen of 10mg/kg IV dosing every two weeks. This approach is crucial for slowing the progression of Alzheimer's and prolonging the therapeutic benefits, helping patients preserve their identity for a more extended period.
The MHRA's decision aligns with recent regulatory approvals in countries like China and the United States, based on positive results from the Phase III Clarity clinical trial. Eisai is leading the development and regulatory submissions for Leqembi worldwide, with Biogen jointly commercializing and promoting the product.
