EU regulator backs Eisai-Biogen Alzheimer’s drug

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The European Union’s drugs regulator on Thursday (November 14, 2024) recommended approval of Eisai and Biogen’s 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.

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 trials, the EU regulator said.