An application for the marketing authorization of lecanemab, a promising treatment for early-stage Alzheimer’s disease, has faced a setback.  The European Medicines Agency (EMA) has issued a negative opinion on the application, causing significant disappointment among stakeholders and patients alike. Despite its previous approvals in the US, Japan, and other regions, lecanemab’s European approval now hangs in the balance.

Alzheimer Europe expressed regret over the EMA’s decision, emphasizing the unmet needs of Alzheimer’s patients in Europe and the potential benefits of lecanemab. They highlighted the drug’s success in reducing clinical decline in trials, noting its effectiveness in slowing the progression of mild cognitive impairment and mild Alzheimer’s dementia.

The EMA’s negative opinion on Eisai’s lecanemab has also implications for the AI-Mind project, which develops AI-based tools for dementia risk prediction in people with mild cognitive impairment (MCI). The decision underscores the importance of accurate and early risk assessment tools like those being developed by AI-Mind. With treatments such as lecanemab facing regulatory hurdles, the need for reliable early detection becomes even more critical. AI-Mind’s innovative approach to predicting dementia risk can help identify individuals who might benefit from early intervention strategies.

The negative opinion from the EMA was influenced by concerns regarding the safety profile of lecanemab, particularly its association with adverse events such as cerebral hemorrhages and infusion-related reactions. 

As the situation develops, the Alzheimer’s community continues to advocate for innovative treatments that can offer hope to millions affected by this debilitating disease.

For more detailed information, you can refer to the full articles on the Alzheimer Europe website.

You can find more details of the CHMP recommendation here: https://www.ema.europa.eu/en/medicines/human/EPAR/leqembi and the Eisai press release here: https://www.eisai.com/news/2024/news202455.html