Biomarkers for neurodegenerative diseases in regulatory decision‐making by the European Medicines Agency
The European Medicines Agency's marketing authorization applications and qualification and scientific advice procedures.One hundred five procedures were analyzed regarding neurodegenerative diseases that discuss biomarkers.We found that acceptance and role of biomarkers differ per disease.Biological plausibility/clinical benefits are essential for biomarker implementation.
Authors
- Angela C. Bradshaw (ORCID: https://orcid.org/0000-0002-3711-6547)
- Peter G. M. Mol (ORCID: https://orcid.org/0000-0002-4262-3180)
- Audrey Hermans
- Viktoriia Starokozhko
- Anna M.G. Pasmooij (ORCID: https://orcid.org/0000-0003-0641-3829)
- Lorenzo Guizzaro (ORCID: https://orcid.org/0000-0002-0390-270X)
- Elisabeth Bakker
- André Elferink
- Loes den Otter
Institutions
- European Medicines Agency (NL)
- University Medical Center Groningen (NL)
- University of Groningen (NL)
- Utrecht University (NL)
- Maastricht University (NL)
- Pharmo Institute (NL)
- Medicines Evaluation Board (NL)
- Alzheimer Europe (LU)
Publication Details
- Journal
- Alzheimer s & Dementia Translational Research & Clinical Interventions
- Published
- 2025-01-01
- DOI
- https://doi.org/10.1002/trc2.70072
- Citations
- 1
- Primary Topic
- Health Systems, Economic Evaluations, Quality of Life
- Type
- article
- Field-Weighted Citation Impact
- 3.13
Funders
- European Federation of Pharmaceutical Industries and Associations
- European Commission
- College ter Beoordeling van Geneesmiddelen
- Innovative Medicines Initiative