Eisai and Biogen Announce CHMP Positive Opinion for Approval of Humanized Anti-Soluble Aggregating Amyloid-Beta (Aβ) Monoclonal Antibody Lecanemab for the Treatment of Adults with Mild Cognitive Impairment Due to Clinically Diagnosed Alzheimer's Disease (AD) and Mild AD Who Are Non-Carriers of Apolipoprotein E ε4 (ApoE ε4) or Heterozygous for Confirmed Amyloid Pathology.
Eisai previously requested a re-examination of the negative opinion issued by the CHMP in July 2024. According to the regulatory procedures of the European Medicines Agency, the European Commission is expected to make a final decision on the Marketing Authorization Application (MAA) for lecanemab within 67 days after receiving the positive opinion from the CHMP.
Lecanemab selectively binds to Aβ aggregates, particularly targeting toxic protofibrils (while also acting on Aβ fibrils, the main component of Aβ plaques), thereby neutralizing and clearing Aβ plaques in the brain.
Currently, about 6.9 million people in Europe are affected by AD, and with the intensification of population aging, this number is expected to nearly double by 2050. AD progressively worsens over time and is divided into different stages, each presenting new challenges for patients and their caregivers. Therefore, there is a significant unmet need for new treatment options that can slow the progression of early AD and reduce the overall burden on patients and society.
Eisai is leading the global development and registration application of Lecanemab, while the product is co-commercialized and promoted by Eisai and Biogen. Among them, Eisai has the final decision-making power.