The Committee for Medicinal Products for Human Use (CHMP) concluded on February 27 that it was not necessary to modify its positive opinion issued in November 2024

Leqembi: advances in authorization for early treatment of Alzheimer's disease

The European Medicines Agency (EMA) has taken a step closer to final approval of Leqembi (lecanemab) as a treatment for early-stage Alzheimer's disease. Following the European Commission's request to review additional information on its safety and clarity on risk minimization measures, the Committee for Medicinal Products for Human Use (CHMP) concluded on February 27 that it was not necessary to modify its positive opinion issued in November 2024.

What is Leqembi and how does it work?

Leqembi, whose active ingredient is lecanemab, is an intravenous treatment designed to reduce beta-amyloid plaques in the brain, one of the key markers of Alzheimer's disease. This drug is intended for people with mild cognitive impairment or mild dementia, and with one or no copies of the ApoE4 gene.

The CHMP recommendation includes the use of Leqembi under controlled access programs and under the supervision of professionals experienced in the diagnosis of Alzheimer's disease.

Next steps for Leqembi approval in Europe

The European Commission will resume the decision process on the authorization of Leqembi following confirmation from the CHMP that it does not require further modifications.

Once approved, the drug will be available under a controlled access program. In turn, the Summary of Product Characteristics (SmPC) will be published in the European Public Assessment Report (EPAR). This document will provide detailed recommendations for the use of the drug.

In addition, monitoring measures, such as MRI scans at key points during treatment, and educational programs for healthcare professionals and patients will be implemented. This includes conducting subsequent safety studies to evaluate possible side effects and ensure the effectiveness of risk minimization measures.

These steps reflect the effort to ensure safe and controlled access to this innovative Alzheimer's therapy.

New hope for patients and their families

At Ace, we believe that the progress towards approval of Leqembi represents a milestone in the treatment of Alzheimer's disease. This drug offers the potential to slow the progression of the disease in its earliest stages, potentially improving the quality of life of patients and their families.

According to Dr. Mercè Boada, Ace's Chief Medical Officer, “the EMA confirmation marks a crucial step towards an innovative and effective treatment for Alzheimer's disease”. Dr. Boada adds that “Leqembi is a clear example of how research and science can transform lives”.

Another step towards a future where Alzheimer's disease is history.

You can read the full update on Leqembi from the EMA here.

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