The Committee for Medicinal Products for Human Use (CHMP) reaffirms positive opinion for Lecanemab in early Alzheimer's disease in the EU

Core Viewpoint - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has reaffirmed its positive opinion for lecanemab (Leqembi®), which is a significant step towards the marketing authorization decision by the European Commission (EC) for the treatment of early Alzheimer's disease [1][2]. Group 1: Lecanemab Overview - Lecanemab is an anti-Aβ monoclonal antibody that targets both toxic protofibrils and Aβ plaques, which are associated with neuronal injury in Alzheimer's disease [3]. - The drug is already approved in multiple markets including the U.S., Japan, China, and the UK, and if approved by the EC, it will be available across all 27 EU member states as well as Iceland, Liechtenstein, and Norway [4][7]. Group 2: Regulatory Process - The EC requested additional safety information regarding lecanemab after the initial CHMP opinion in November 2024, but the CHMP concluded that no update to its positive opinion was necessary [2]. - A supplemental Biologics License Application (sBLA) for less frequent intravenous maintenance dosing was approved by the U.S. FDA in January 2025, and a rolling submission for a subcutaneous auto-injection formulation is underway with a PDUFA date set for August 31, 2025 [8]. Group 3: Clinical Trials and Research - Eisai's Phase 3 clinical study (AHEAD 3-45) with lecanemab in individuals with preclinical Alzheimer's disease is ongoing and was fully recruited in October 2024 [9]. - The Tau NexGen clinical study for Dominantly Inherited Alzheimer's Disease (DIAD) is also ongoing and includes lecanemab as a key therapy [10]. Group 4: Collaboration and Commercialization - BioArctic has a long-term collaboration with Eisai for the development and commercialization of lecanemab, with Eisai responsible for clinical development and market approval [11]. - BioArctic retains rights to commercialize lecanemab in the Nordic region and is preparing for its commercialization in collaboration with Eisai [11][12].