After re-examining its initial opinion, EMA’s human medicines committee (CHMP) has recommended granting a marketing authorisation to Leqembi (lecanemab) for treating mild cognitive impairment (memory and thinking problems) or mild dementia due to Alzheimer’s disease (early Alzheimer’s disease) in patients who have only one or no copy of ApoE4, a certain form of the gene for the protein apolipoprotein E.
Patients with only one or no copy of ApoE4 are less likely to experience amyloid-related imaging abnormalities (ARIA) than people with two ApoE4 copies. ARIA is a recognised serious side effect with Leqembi that involves swelling and potential bleeding in the brain.
The CHMP concluded that, in the restricted population assessed in the re-examination, the benefits of Leqembi in slowing down progression of symptoms of the disease are greater than its risks. In July 2024, the Committee had issued a negative opinion on the use of Leqembi in a broader population of all patients with early Alzheimer’s disease…
