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After re-examining its initial opinion, the European Medicines Agency’s (EMA) human medicines committee (CHMP) has recommended granting marketing authorisation to Leqembi (lecanemab) for treating mild cognitive impairment (memory and thinking problems) or mild dementia due to early Alzheimer’s disease in patients who have only one or no copy of ApoE4, a 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) compared to those with two ApoE4 copies. ARIA is a recognised serious side-effect with Leqembi, marked by 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 the progression of the 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.
The CHMP concluded that in patients who have one or no copy of ApoE4, the benefits outweigh the risks in using Leqembi to treat mild cognitive impairment or mild dementia due to Alzheimer’s disease, provided that measures are in place to minimise the risk of severe and symptomatic ARIA, and monitor its long-term consequences.
Leqembi will be available through a controlled access programme to ensure the medicine is only used in the recommended patient population. Patients will need to have MRI scans to monitor for ARIA before initiation of treatment and before the 5th, 7th and 14th doses of Leqembi.
Additional MRI scans may be needed at any time during treatment if patients develop symptoms of ARIA (such as headache, confusion, visual changes, dizziness, nausea, and difficulty in walking).
(Source: EMA)
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