Comment by European Alzheimer's Disease Consortium (EADC) investigators on the negative recommendation of the CHMP on the marketing authorization of donanemab for early Alzheimer' s disease

• Authors: JESSEN Frank; ARBIZU Javier; BOADA Merce; BALASA Mircea; BENNYS Karim; BOBAN Marina; BURGER Katharina; CHINCARINI Andrea; CAGNIN Annachiara; PAUL De Deyn Peter; DUEZEL Emrah; ENGELBORGHS Sebastiaan; EWERS Michael; EXALTO Lieza G; VAN DER FLIER Wiesje M; FORTEA Juan; FREDERIKSEN Kristian Steen; FRISONI Giovanni B; FROELICH Lutz; GARZA-MARTINEZ Alejandro J; GRIMMER Timo; HANSEEUW Bernard; HORT Jakub; IVANOIU Adrian; KEHOE Patrick G; KENNELLY Sean P; KERN Silke; KLOEPPEL Stefan; KRAJČOVIČOVÁ Lenka; KRAMBERGER Milica G; MCGUINNESS Bernadette; MECOCCI Patrizia; OBERSTEIN Timo Jan; OUSSET Pierre-Jean; PAQUET Claire; PERNECZKY Robert; PIAZZA Fabrizio; PLANTONE Domenico; RAINERO Innocenzo; SACCO Guillaume; SALM Eric; SANTANA Isabel; SCARMEAS Nikolaos; SCHNEIDER Anja; SCHOTT Jonathan M; SOLJE Eino; STEFANOVA Elka; STOGMANN Elisabeth; STRAUSS Melanie; SUTOVSKY Stanislav; WALDEMAR Gunhild; WINBLAD Bengt
• Year of publication: 2025
• Type: Article in Periodical
• Magazine / Source: JPAD-JOURNAL OF PREVENTION OF ALZHEIMERS DISEASE
• MU Faculty or unit: Faculty of Medicine
• web: https://www.sciencedirect.com/science/article/pii/S227458072500202X?via%3Dihub
• Doi: https://doi.org/10.1016/j.tjpad.2025.100259
• Keywords: Alzheimer’s Disease; donanemab
• Description: On March 27th, 2025 the Committee for Medical Product for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the refusal of the marketing authorization of donanemab for the treatment of early Alzheimer disease (AD), while on November 14th 2024 the same committee gave a positive recommendation for lecanemab for the same indication. Lecanemab was fully approved by the European Commission on the 15th of April 2025. The rationale for the CHMP’s opposing recommendation remains unclear. Lecanemab and donanemab are comparable in efficacy. In fact, the donanemab vs. placebo difference at 18 months was 0.67 points on the Clinical Dementia Rating Sum of Boxes (CDR-SB) in the phase 3 clinical study TRAILBLAZER-ALZ 2, while it was 0.45 points in the lecanemab phase 3 study CLARITY-AD.