CHMP backs Lecanemab again for early Alzheimer’s as EC reviews approval

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has reaffirmed its positive opinion on lecanemab, a monoclonal antibody therapy developed by Eisai Co., Ltd. and Biogen Inc. for the treatment of early Alzheimer’s disease. This development brings the drug one step closer to potential European approval, as the European Commission (EC) now resumes its regulatory review to determine whether lecanemab will receive marketing authorization.

The CHMP had originally issued a positive recommendation for lecanemab in November 2024, but the European Commission later requested a reassessment of additional safety data before moving forward with a final decision. This review focused on evaluating whether newly available safety information required any modifications to the CHMP’s original risk assessment and whether the risk minimization measures outlined in the previous opinion were sufficiently clear for healthcare providers. After reviewing the data, CHMP concluded that no changes were necessary, reaffirming its support for lecanemab’s approval.

How Does Lecanemab Work in Early Alzheimer’s Disease?

Lecanemab is a humanized monoclonal antibody specifically designed to target amyloid-beta (Aβ) protein deposits, which are believed to contribute to the progression of early Alzheimer’s disease. The drug binds to soluble protofibrils and insoluble amyloid plaques, helping to reduce their presence in the brain. This anti-amyloid approach aligns with growing scientific consensus that removing amyloid buildup may slow the progression of early Alzheimer’s disease.

Lecanemab is the result of a long-standing strategic research partnership between Eisai and BioArctic, dating back to 2005. Eisai has been responsible for the global development, manufacturing, and commercialization of the drug since acquiring worldwide rights in 2007.

Where Has Lecanemab Already Been Approved?

Lecanemab has secured regulatory approvals in multiple countries, including the United States, Japan, China, South Korea, Hong Kong, Israel, the United Kingdom, Mexico, Macau, Oman, and the United Arab Emirates. Beyond these approvals, the therapy remains under regulatory review in 18 countries and regions, including the European Union.

In January 2025, the U.S. Food and Drug Administration (FDA) approved a Supplemental Biologics License Application (sBLA) allowing once-every-four-weeks maintenance dosing for patients. Additionally, the FDA accepted a Biologics License Application (BLA) for a subcutaneous injection formulation, which is being developed to enhance patient convenience and increase accessibility for individuals receiving long-term treatment.

What Clinical Trials Support Lecanemab’s Effectiveness?

Lecanemab has undergone rigorous testing in clinical trials aimed at demonstrating its effectiveness and safety in treating early Alzheimer’s disease. One of the most significant ongoing studies is the AHEAD 3-45 trial, which began in July 2020. This Phase 3 study focuses on individuals who are clinically normal but have elevated amyloid levels in their brains, indicating a preclinical stage of Alzheimer’s disease. The trial is being conducted as a public-private collaboration between Eisai, Biogen, and the Alzheimer’s Clinical Trial Consortium, with funding from the National Institute on Aging, a division of the National Institutes of Health.

Another key study is the Tau NexGen clinical trial, which launched in January 2022. This study, led by the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) at Washington University School of Medicine in St. Louis, evaluates lecanemab’s role in treating Dominantly Inherited Alzheimer’s Disease (DIAD). As part of this research, lecanemab serves as the backbone anti-amyloid therapy, testing its effectiveness in slowing the neurodegenerative process in patients with genetically inherited Alzheimer’s disease.

What Is the Significance of Lecanemab for Alzheimer’s Treatment?

Alzheimer’s disease represents a significant and growing public health crisis, with an estimated 15.2 million individuals in Europe affected by mild cognitive impairment (MCI) due to Alzheimer’s disease, and an additional 6.9 million diagnosed with Alzheimer’s dementia. Given that early Alzheimer’s disease progresses in distinct stages, treatments that can slow cognitive decline hold immense value for patients, caregivers, and the healthcare system.

The development of anti-amyloid therapies such as lecanemab reflects a shift in Alzheimer’s treatment, moving away from symptom management toward disease-modifying interventions that target the underlying causes of neurodegeneration. While challenges remain in terms of patient selection, treatment access, and long-term monitoring, the availability of innovative therapies like lecanemab provides new hope for slowing the progression of early Alzheimer’s disease.

What Happens Next for Lecanemab in Europe?

With the CHMP reaffirming its positive stance on lecanemab, the next step rests with the European Commission, which will determine whether to grant marketing authorization across the European Union. If approved, the decision will apply to all 27 EU member states, as well as Iceland, Liechtenstein, and Norway.

Both Eisai and Biogen have reiterated their commitment to ensuring that lecanemab reaches patients with early Alzheimer’s disease in Europe as soon as possible. Given the growing demand for effective treatment options, an approval from the European Commission would mark a significant step forward in addressing the unmet medical need in Alzheimer’s care.

The CHMP’s reaffirmation of its positive opinion on lecanemab signals continued confidence in its potential benefits for early Alzheimer’s disease patients. With global regulatory approvals expanding and new clinical research supporting its therapeutic potential, lecanemab remains at the forefront of Alzheimer’s disease treatment innovation. As the European Commission moves closer to a final decision, the outcome could shape the future landscape of anti-amyloid therapies in Europe, offering new treatment possibilities for millions of individuals affected by early Alzheimer’s disease.