- In the UK, lecanemab is approved for the treatment of mild cognitive impairment and mild Alzheimer's disease (AD) of AD origin in adult patients who are either heterozygous or non-carriers of apolipoprotein E ε4 (ApoE ε4).
- The UK becomes the first European country to approve the use of this drug targeting the potential cause of Alzheimer's disease.
Eisai and Biogen Announce Approval of Leqembi™ (Lecanemab), a Humanized Anti-Soluble Aggregating Amyloid-Beta (Aβ) Monoclonal Antibody, by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the Treatment of Mild Cognitive Impairment Due to Alzheimer's Disease (AD) and Mild AD in Adult Patients Who Are ApoE ε4 Heterozygous or Non-Carriers. Leqembi is the first treatment approved in a European country targeting the underlying cause of early Alzheimer’s disease (mild cognitive impairment due to Alzheimer’s disease or mild dementia).
Lecanemab can selectively bind to Aβ aggregates, particularly targeting toxic protofibrils (while also acting on Aβ fibrils, the main component of Aβ plaques), thereby neutralizing and clearing Aβ plaques in the brain.
This approval is mainly based on Eisai's Phase 3 clinical research data (CLARITY AD, a global, randomized, double-blind, parallel-group, placebo-controlled study). In this trial, lecanemab achieved the primary endpoint (change from baseline in Clinical Dementia Rating Scale Sum of Boxes [CDR-SB] at 18 months) and all key secondary endpoints, with results showing significant statistical significance. In the applicable population in the UK, the most common adverse reactions were infusion-related reactions, amyloid-related imaging abnormalities with hemorrhage (microbleeds) (ARIA-H), falls, headache, and amyloid-related imaging abnormalities with cerebral edema (ARIA-E).
It is estimated that there are 982,000 people with dementia in the UK, and 60%-70% of dementia cases are caused by Alzheimer's disease. These numbers are expected to rise as the population ages.
Eisai is collaborating with the National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC), and the National Health Service (NHS) to make this drug available as soon as possible to eligible patients with early-stage Alzheimer's disease.
Eisai is leading the global development and registration application of lecanemab, while the product will be jointly commercialized and promoted by Eisai and Biogen. Among them, Eisai has the final decision-making power. In the UK, Eisai and Biogen will jointly be responsible for the commercial promotion of the product, and Eisai will distribute the product as the marketing authorization holder.