EMA recommends Leqembi for treatment of early Alzheimer’s disease

The EMA stated: “After re-examining its initial opinion, EMA’s human medicines committee, or CHMP, has recommended granting a marketing authorisation to Leqembi for treating mild cognitive impairment or mild dementia due to 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, or 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.”