CHMP Reaffirms Positive Opinion for Lecanemab in Early Alzheimer's Disease Treatment in the EU

Reaffirming Progress: Lecanemab and Early Alzheimer's Disease Treatment

On February 28, 2025, BioArctic AB's partner, Eisai, announced a significant development in the fight against Alzheimer's disease. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has reaffirmed its positive opinion on lecanemab (Leqembi®), a groundbreaking treatment targeting early-stage Alzheimer's disease. This decision is critical as it paves the way for progressing marketing authorization in the European Union.

In November 2024, the CHMP had initially adopted a favorable opinion regarding lecanemab. Following a thorough examination of additional safety information requested by the European Commission (EC), the CHMP concluded that its original positive assessment remains unchanged. This decision reassures both healthcare professionals and patients of the potential benefits of this innovative therapy.

Lecanemab is an Aβ monoclonal antibody that specifically targets toxic protofibrils—soluble aggregates of amyloid-beta—and works to reduce Aβ plaques found in the brains of those with Alzheimer's disease. Disturbingly, Aβ protofibrils are a highly toxic form that contribute to neuronal injury and disease progression. Thus, lecanemab presents a dual action: targeting both the aggregates and the plaques crucial to the disease's advancement.

If the European Commission grants marketing authorization, the approval will extend across all 27 EU member states, as well as Iceland, Liechtenstein, and Norway. Lecanemab is already available in several markets including the United States, Japan, and China, bolstering its international reach. Eisai and BioArctic remain dedicated to ensuring that lecanemab becomes accessible to early Alzheimer's patients as promptly as possible.

The safety and efficacy of lecanemab were primarily evidenced in the global Clarity AD clinical trial, where it achieved its primary endpoint along with all key secondary endpoints with statistically significant results. Furthermore, the U.S. Food and Drug Administration (FDA) recently approved a supplemental Biologics License Application for maintenance dosing of lecanemab, ensuring patients receive optimal care with less frequent intravenous administration.

Research on lecanemab continues, with ongoing clinical trials such as the AHEAD 3-45, which studies individuals with preclinical Alzheimer's, and the Tau NexGen trial focusing on genetically inherited Alzheimer's. These studies underline the commitment to understanding and battling Alzheimer's on multiple fronts, ensuring optimal efficacy and patient care.

The collaboration between BioArctic and Eisai has been instrumental since its inception in 2005, focusing on the development of medications for Alzheimer's disease. Notably, the partnership has yielded agreements allowing for the development and commercialization of lecanemab, emphasizing a shared objective of addressing this neurodegenerative crisis.

BioArctic, a Swedish biopharma company, is dedicated to pioneering treatments that can modify the course of neurodegenerative conditions. The company’s commitment to innovation is evident in its comprehensive pipeline, which also explores therapies for Parkinson's disease and ALS. With the potential for lecanemab to become the first drug to slow the progression of early Alzheimer's, stakeholders are optimistic about its future in the global healthcare landscape.

In conclusion, the reaffirmation from the CHMP regarding lecanemab is a substantial step forward in the fight against early Alzheimer's disease. As regulatory processes continue, the focus remains on ensuring that patients receive timely access to this promising therapeutic option, enhancing hope and quality of life for individuals affected by this challenging condition.