Overview
- After an initial 18 months of 10 mg/kg intravenous dosing every two weeks, eligible patients may switch to 10 mg/kg every four weeks or continue the biweekly schedule.
- The ruling builds on the UK’s August 2024 authorization that covered adults with mild cognitive impairment or mild dementia due to Alzheimer’s who are ApoE ε4 non-carriers or heterozygotes.
- MHRA’s action is consistent with recent approvals in the US and China and draws on Clarity AD Phase 3 results that met primary and key secondary endpoints.
- Sponsors emphasize continued maintenance therapy to preserve benefit because Alzheimer’s biomarkers can reaccumulate and clinical decline can revert to placebo rates after stopping treatment.
- Eisai leads development and regulatory strategy with Biogen as co-commercialization partner, BioArctic retains Nordic rights, and Leqembi is now approved in 51 countries with a US subcutaneous maintenance autoinjector already cleared.