The European Commission approves Leqembi®

The Alzheimer’s disease drug, Leqembi® (lecanemab), has been approved by the European Commission following extra reviews of the product’s safety. The decision was announced on 16 April by the product’s co-developer BioArctic AB which will make the drug available to adults with a clinical diagnosis of mild cognitive impairment and mild dementia due to Alzheimer’s disease. The patient group is specifically identified as people who have only one, or no copy, of the ApoE4 gene, a risk factor for the disease.

The European Medicines Agency’s main scientific committee initially rejected the Leqembi application on the grounds that the drug’s ability to delay cognitive decline was not sufficient to offset the risk of a side effect known as amyloid-related imaging abnormalities (ARIA). There are two types of ARIA. ARIA-E is characterised by the accumulation of fluid in the brain. ARIA-H is associated with bleeding. The side effects are highest in patients with two copies of the ApoE4 gene.

On appeal from the developer, the EMA re-examined its initial decision focusing on a sub-group of patients with one or no copy of the ApoE4 gene and proposed approval. The reexamination showed that 8.9% of patients treated with Leqembi with one or no copy of the gene experienced ARIA-E compared with 12.6% of all patients. Similarly, 12.9% of patients with one or no copy of the gene experienced ARIA-H compared with 16.9% in the broader population. The effectiveness of the drug was largely similar for all patients. The Commission initially refused to accept the results of the appeal. But after further clarification of the risk minimisation measures, it approved the drug.

^{This document has been prepared by Jean-Claude Muller and is provided for information purposes only. The information contained herein has been obtained from sources believed to be reliable but is not warranted to be accurate or complete. The views presented are those of the author at the time of writing and are subject to change. Jean-Claude Muller has no obligation to update these opinions or the information presented.}