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EMA Reverses Decision, Recommends Limited Approval for Eisai and Biogen’s Alzheimer’s Drug Leqembi

NextEdge Admin

15 Nov 2024

2 min 22 sec

The European Medicines Agency (EMA) has reversed its previous stance on Eisai and Biogen’s Alzheimer’s drug Leqembi, now recommending approval for treating mild cognitive impairment or mild dementia due to Alzheimer’s. Approval is limited to patients with one or no copies of the ApoE4 gene due to a higher risk of amyloid-related imaging abnormalities (ARIA), such as brain swelling or bleeding, in those with two ApoE4 copies.

Following subgroup analyses requested by Eisai, the EMA found that ARIA incidence in patients with one or no ApoE4 copies was 8.9% (brain swelling) and 12.9% (bleeding), compared to 12.6% and 16.9% in the broader population. Additionally, after 18 months, patients in the restricted group had slower cognitive decline with Leqembi, as indicated by a smaller increase on the CDR-SB scale: 1.22 points with Leqembi vs. 1.75 with placebo.

The EMA also considered input from patients, caregivers, and clinicians, who emphasized the unmet needs in Alzheimer’s treatment. As a condition, Leqembi will be available only through a controlled access program with mandatory MRI scans to monitor for ARIA at specific treatment points. Eisai will conduct a post-marketing safety study on ARIA and set up an EU registry to track real-world data on side effects and Alzheimer’s progression.

The EMA’s recommendation now moves to the European Commission for final marketing authorization. The U.K.’s MHRA has similarly restricted Leqembi by ApoE4 status, while the U.S. FDA has granted broader approval.