European agency takes comments on Alzheimer's biomarkers

The European Medicines Agency (EMA) is looking for public comment on the first clinical biomarker the agency has approved for use in humans, according to a report in PharmaTimes.

The EMA responded favorably to the use of two cerebral spinal fluid biomarkers for use in clinical trials in pre-dementia Alzheimer's disease. The opinion is open for comments until March 23 and was requested by Bristol-Myers Squibb. Low levels of the protein Aβ1-42 and high levels of the protein T-tau in the cerebrospinal fluid of patients with mild cognitive impairment appear to be linked to a higher risk of developing Alzheimer's disease-related dementia, PharmaTimes reports.

EMA qualification is a new, voluntary pathway leading to either an opinion by the Committee for Medicinal Products for Human Use or scientific advice on novel methodologies or drug development tools, the report said.

- read the PharmaTimes report
- visit the EMA's website