The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) recommended that the monoclonal antibody lecanemab (commercial name Leqembi) receive a marketing authorisation after it completed a re-examination procedure. The medicine is used to treat patients with mild cognitive deficits (impairment of memory and thought) or mild dementia as a result of early Alzheimer's disease. Marketing authorisation is only recommended for treatment of patients who only have one copy of the ApoE4 gene or those who don't carry the gene at all. Leqembi will be made available in the context of controlled access programmes in order to ensure that the medicinal product will only be used for the recommended patients. The EU Commission takes the decision on the authorisation, and it usually follows the recommendation of the CHMP.
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In July 2024, the Committee issued a negative opinion on the possibility of using Leqembi to treat all patients in the early stages of Alzheimer's disease. A re-examination was conducted after the applicant submitted an analysis of data from a patient subgroup from the main study. This analysis shows that patients with only one or no ApoE4 copy are less likely to experience ARIA (amyloid-related imaging abnormality) as a side effect than patients with two ApoE4 copies. ARIA is a known side effect of anti-amyloid antibodies that is associated with swelling and bleeding in the brain.
In its review of the submitted data, the CHMP concluded that the benefits of lecanemab in terms of slowing disease progression are greater than the risks for the restricted patient population.
Leqembi will only be prescribed within the context of controlled access programmes. The programme will require patients to undergo magnetic resonance imaging examinations to monitor for ARIA before starting treatment and before the fifth, seventh and fourteenth doses of the monoclonal antibody. Additional examinations may be required at any point during treatment.
Updated: 21.11.2024
