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Eisai/Handout via REUTERS The Alzheimer’s drug LEQEMBI is seen in this undated handout image obtained by Reuters on January 20, 2023.
Reuters
15:15 JST, November 15, 2024
The European Union’s drugs regulator on Thursday recommended approval of Eisai 4523.T and Biogen’s BIIB.O Leqembi for some patients with early Alzheimer’s disease, reversing its initial decision from four months ago.
The backing could make it the EU’s first treatment for the brain-wasting condition if this recommendation is accepted by the European Commission.
The regulator’s human medicines committee (CHMP) recommended approval for a narrower set of patients than those evaluated in the drug’s trial.
Eisai and Biogen had tested the drug in patients with one or no copy of the ApoE4 gene variant, which is linked with an earlier onset of the disease. The trial also included patients who had two copies of the gene variant.
In July, the regulator rejected the drug saying that the risk of serious brain swelling did not outweigh its small impact on slowing cognitive decline.
The agency said benefits of Leqembi in slowing down progression of disease symptoms are greater than its risks in patients with one or no copy of the gene variant, which was assessed during the re-examination.
“This population accounted for about 80%-85% of patients in the Phase 3 study — though we believe it may be closer to about 60% in the real world,” said Jefferies analyst Michael Yee.
In the United States, Leqembi is also approved for patients who have two copies of the gene ApoE4.
For the re-assessment, the drugmakers provided an analysis of 1,521 patients — who have one or no ApoE4 copy — from the main study, out of total of 1,795 patients.
Patients with only one or no copy of ApoE4 are less likely to experience serious side effects of brain swelling and potential bleeding seen in Leqembi trials, the EU regulator said.
The EU could account for up to 30% of worldwide peak sales for the drugmakers, Yee said, but they face other launch-related challenges as the drug requires additional diagnostic tests and regular brain scans.
Yee added that the recommendation could help justify pricing and reimbursement for the drug, which is decided at the level of each EU member state after authorisation is granted.
