The European Medicines Agency (EMA) is seeking 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 of 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.
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.