Swedish research-based biopharma company BioArctic AB (STO:BIOA-B) and its Japanese partner Eisai Co Ltd (TYO:4523) announced on Thursday that the UK's Medicines and Healthcare products Regulatory Agency (MHRA) has approved Leqembi (lecanemab) for once every four weeks intravenous (IV) maintenance dosing for the treatment of early Alzheimer's disease.
Leqembi was previously approved for the treatment of mild cognitive impairment (MCI) and mild dementia due to Alzheimer's disease (AD) in adult patients that are apolipoprotein E e4 (ApoE e4) heterozygotes or non-carriers in the UK.
The latest approval for IV maintenance dosing, after 18 months of a dosing regimen of 10 mg/kg once every two weeks, allows patients to be transitioned to a maintenance dosing regimen of 10 mg/kg once every four weeks, or they may continue with 10 mg/kg once every two weeks.
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