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
JESSEN, Frank; Javier ARBIZU; Merce BOADA; Mircea BALASA; Karim BENNYS et al.
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
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JESSEN, Frank; Javier ARBIZU; Merce BOADA; Mircea BALASA; Karim BENNYS; Marina BOBAN; Katharina BURGER; Andrea CHINCARINI; Annachiara CAGNIN; De Deyn Peter PAUL; Emrah DUEZEL; Sebastiaan ENGELBORGHS; Michael EWERS; Lieza G EXALTO; Wiesje M VAN DER FLIER; Juan FORTEA; Kristian Steen FREDERIKSEN; Giovanni B FRISONI; Lutz FROELICH; Alejandro J GARZA-MARTINEZ; Timo GRIMMER; Bernard HANSEEUW; Jakub HORT; Adrian IVANOIU; Patrick G KEHOE; Sean P KENNELLY; Silke KERN; Stefan KLOEPPEL; Lenka KRAJČOVIČOVÁ; Milica G KRAMBERGER; Bernadette MCGUINNESS; Patrizia MECOCCI; Timo Jan OBERSTEIN; Pierre-Jean OUSSET; Claire PAQUET; Robert PERNECZKY; Fabrizio PIAZZA; Domenico PLANTONE; Innocenzo RAINERO; Guillaume SACCO; Eric SALM; Isabel SANTANA; Nikolaos SCARMEAS; Anja SCHNEIDER; Jonathan M SCHOTT; Eino SOLJE; Elka STEFANOVA; Elisabeth STOGMANN; Melanie STRAUSS; Stanislav SUTOVSKY; Gunhild WALDEMAR a Bengt WINBLAD
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JPAD-JOURNAL OF PREVENTION OF ALZHEIMERS DISEASE, AMSTERDAM, ELSEVIER, 2025, 2274-5807
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.
JESSEN, Frank; Javier ARBIZU; Merce BOADA; Mircea BALASA; Karim BENNYS; Marina BOBAN; Katharina BURGER; Andrea CHINCARINI; Annachiara CAGNIN; De Deyn Peter PAUL; Emrah DUEZEL; Sebastiaan ENGELBORGHS; Michael EWERS; Lieza G EXALTO; Wiesje M VAN DER FLIER; Juan FORTEA; Kristian Steen FREDERIKSEN; Giovanni B FRISONI; Lutz FROELICH; Alejandro J GARZA-MARTINEZ; Timo GRIMMER; Bernard HANSEEUW; Jakub HORT; Adrian IVANOIU; Patrick G KEHOE; Sean P KENNELLY; Silke KERN; Stefan KLOEPPEL; Lenka KRAJČOVIČOVÁ; Milica G KRAMBERGER; Bernadette MCGUINNESS; Patrizia MECOCCI; Timo Jan OBERSTEIN; Pierre-Jean OUSSET; Claire PAQUET; Robert PERNECZKY; Fabrizio PIAZZA; Domenico PLANTONE; Innocenzo RAINERO; Guillaume SACCO; Eric SALM; Isabel SANTANA; Nikolaos SCARMEAS; Anja SCHNEIDER; Jonathan M SCHOTT; Eino SOLJE; Elka STEFANOVA; Elisabeth STOGMANN; Melanie STRAUSS; Stanislav SUTOVSKY; Gunhild WALDEMAR a Bengt WINBLAD. 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. JPAD-JOURNAL OF PREVENTION OF ALZHEIMERS DISEASE. AMSTERDAM: ELSEVIER, 2025, roč. 12, č. 8, s. 1-5. ISSN 2274-5807. Dostupné z: https://doi.org/10.1016/j.tjpad.2025.100259.
@article{2523925, author = {Jessen, Frank and Arbizu, Javier and Boada, Merce and Balasa, Mircea and Bennys, Karim and Boban, Marina and Burger, Katharina and Chincarini, Andrea and Cagnin, Annachiara and Paul, De Deyn Peter and Duezel, Emrah and Engelborghs, Sebastiaan and Ewers, Michael and Exalto, Lieza G and van der Flier, Wiesje M and Fortea, Juan and Frederiksen, Kristian Steen and Frisoni, Giovanni B and Froelich, Lutz and GarzaandMartinez, Alejandro J and Grimmer, Timo and Hanseeuw, Bernard and Hort, Jakub and Ivanoiu, Adrian and Kehoe, Patrick G and Kennelly, Sean P and Kern, Silke and Kloeppel, Stefan and Krajčovičová, Lenka and Kramberger, Milica G and McGuinness, Bernadette and Mecocci, Patrizia and Oberstein, Timo Jan and Ousset, PierreandJean and Paquet, Claire and Perneczky, Robert and Piazza, Fabrizio and Plantone, Domenico and Rainero, Innocenzo and Sacco, Guillaume and Salm, Eric and Santana, Isabel and Scarmeas, Nikolaos and Schneider, Anja and Schott, Jonathan M and Solje, Eino and Stefanova, Elka and Stogmann, Elisabeth and Strauss, Melanie and Sutovsky, Stanislav and Waldemar, Gunhild and Winblad, Bengt}, article_location = {AMSTERDAM}, article_number = {8}, doi = {https://doi.org/10.1016/j.tjpad.2025.100259}, keywords = {Alzheimer’s Disease; donanemab}, language = {eng}, issn = {2274-5807}, journal = {JPAD-JOURNAL OF PREVENTION OF ALZHEIMERS DISEASE}, title = {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}, url = {https://www.sciencedirect.com/science/article/pii/S227458072500202X?via%3Dihub}, volume = {12}, year = {2025} }
TY - JOUR ID - 2523925 AU - 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 PY - 2025 TI - 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 JF - JPAD-JOURNAL OF PREVENTION OF ALZHEIMERS DISEASE VL - 12 IS - 8 SP - 1-5 EP - 1-5 PB - ELSEVIER SN - 22745807 KW - Alzheimer’s Disease KW - donanemab UR - https://www.sciencedirect.com/science/article/pii/S227458072500202X?via%3Dihub N2 - 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. ER -
JESSEN, Frank; Javier ARBIZU; Merce BOADA; Mircea BALASA; Karim BENNYS; Marina BOBAN; Katharina BURGER; Andrea CHINCARINI; Annachiara CAGNIN; De Deyn Peter PAUL; Emrah DUEZEL; Sebastiaan ENGELBORGHS; Michael EWERS; Lieza G EXALTO; Wiesje M VAN DER FLIER; Juan FORTEA; Kristian Steen FREDERIKSEN; Giovanni B FRISONI; Lutz FROELICH; Alejandro J GARZA-MARTINEZ; Timo GRIMMER; Bernard HANSEEUW; Jakub HORT; Adrian IVANOIU; Patrick G KEHOE; Sean P KENNELLY; Silke KERN; Stefan KLOEPPEL; Lenka KRAJČOVIČOVÁ; Milica G KRAMBERGER; Bernadette MCGUINNESS; Patrizia MECOCCI; Timo Jan OBERSTEIN; Pierre-Jean OUSSET; Claire PAQUET; Robert PERNECZKY; Fabrizio PIAZZA; Domenico PLANTONE; Innocenzo RAINERO; Guillaume SACCO; Eric SALM; Isabel SANTANA; Nikolaos SCARMEAS; Anja SCHNEIDER; Jonathan M SCHOTT; Eino SOLJE; Elka STEFANOVA; Elisabeth STOGMANN; Melanie STRAUSS; Stanislav SUTOVSKY; Gunhild WALDEMAR a Bengt WINBLAD. 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. \textit{JPAD-JOURNAL OF PREVENTION OF ALZHEIMERS DISEASE}. AMSTERDAM: ELSEVIER, 2025, roč.~12, č.~8, s.~1-5. ISSN~2274-5807. Dostupné z: https://doi.org/10.1016/j.tjpad.2025.100259.