The European Medicines Agency (EMA) has released for public consultation its first qualification opinion on a clinical biomarker for use in humans.
The positive opinion, which related to the use of two cerebral spinal fluid (CSF) biomarkers to select patients for clinical trials in pre-dementia Alzheimer’s disease, was in response to a request from Bristol-Myers Squibb. The opinion is open for comments until 23 March 2011.
Adopted by the EMA’s Committee for Medicinal Products for Human Use (CHMP) on the recommendation of its Scientific Advice Working Party, the draft opinion states that low levels of the protein A_1-42 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.
As both proteins are difficult to measure, laboratories will need to follow international guidelines and standardised quality control procedures during this process, the CHMP notes.
EMA qualification is a new, voluntary scientific pathway leading to either a CHMP opinion or scientific advice on novel methodologies or drug development tools.
That includes qualification of biomarkers developed by research consortia, networks, public/private partnerships, learned societies or industry for a specific intended use in pharmaceutical research and development.
In October 2010, the EMA issued an opinion on a biomarker to predict kidney damage in rats.