Europe: European Medicines Agency Adopts Two Alzheimers Biomarkers
Under a voluntary new scientific pathway, the European Medicines Agency (EMA) adopted two innovative biomarkers for use in the development of new medications for Alzheimers submitted by Bristol-Myers Squibb: PET amyloid imaging (positive/ negative) as a biomarker for enrichment for use in predementia AD clinical trials, and use of CSF AB 1-42 and t-tau and/or PET-amyloid imaging (positive/ negative).
The new process can lead to either a Committee for Medicinal Products for Human Use (CHMP) opinion or a Scientific Advice and is open to biomarkers developed by consortia, networks, public/private partnerships, learned societies or pharmaceutical industry for a specific intended use in pharmaceutical research and development.
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CSF AB 1-42 and t-tau and/or PET-amyloid imaging (positive/ negative)