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After re-examining its initial opinion, the EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended that Leqembi (lecanemab) be given marketing authorization for the treatment of 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 copy or no copy of ApoE4, a particular form of the gene for the protein apolipoprotein E, is shown in the official release.
Patients with only one or no copies of the ApoE4 gene have a lower risk of developing imaging abnormalities associated with amyloid deposits (ARIA) than those with two copies of ApoE4. ARIA is an important side effect associated with treatment with Leqembi, a drug intended to slow the progression of Alzheimer’s disease. This condition includes edema (swelling) and potential brain bleeding, which can have serious health implications for patients.
After re-evaluating the data, the Committee for Medicinal Products for Human Use (CHMP) concluded that, for a small group of patients, the benefits of Leqembi in slowing the progression of Alzheimer’s symptoms are greater than its risks. This decision came after a negative opinion issued in July 2024, in which the CHMP recommended against the use of Leqembi for all patients with early-stage Alzheimer’s, considering that the risks may outweigh the benefits in the wider population.
Data show a lower risk of ARIA in some patients
ARIA comes in two forms: ARIA-E (edema) which involves the accumulation of fluid in the brain and ARIA-H (hemorrhage) which involves small bleeds in the brain. This can occur naturally in all Alzheimer’s patients, but is exacerbated by taking drugs such as Leqembi, which are antibodies that target beta-amyloid. In the review requested by the company, the CHMP considered subgroup analyzes that excluded data from patients carrying 2 copies of the ApoE4 gene and therefore at the highest risk of ARIA.
The results of these analyzes showed that among patients treated with Leqembi, 8.9% of those with a single copy or no copy of ApoE4 experienced ARIA-E, compared with 12.6% of all patients; similarly, 12.9% of patients in the restricted population had ARIA-H compared with 16.9% in the wider population.
Among patients treated with placebo (a dummy treatment), the figures were 1.3% and 6.8% for ARIA-E and ARIA-H, respectively, in the restricted population.
Data on benefits in the restricted population
In terms of efficacy, the benefits of Leqembi in the narrow population are consistent with those seen in the wider population. For the review, the company provided a subgroup analysis of data from the main study that included 1,521 patients who have one or no copies of ApoE4 out of a total of 1,795 patients. The main measure of effectiveness was a change in cognitive and functional symptoms after 18 months, measured using a dementia rating scale known as the CDR-SB. The scale ranges from 0 to 18, with higher scores indicating greater impairment.
After 18 months of treatment, patients treated with Leqembi had a smaller increase in CDR-SB score than those receiving placebo (1.22 versus 1.75), indicating slower cognitive decline. Results for other key measures were similar to those observed with the CDR-SB scale.
Source: www.doctorulzilei.ro
