FDA focus on French Biotrial Phase 1 Tragedy
FDA Brief : Week of Jan 25, 2016
Drug Information Update-FDA works with regulatory partners to understand French-based Biotrial phase 1 clinical study
- Conferring with European regulators regarding the tragic phase 1 clinical study, conducted by Biotrial that resulted in 1 death and 4 neurological injuries
- BIA 10-2474 is inhibitor of fatty acid amide hydrolase (FAAH), an enzyme involved in cell function in the nervous system
- FDA is collecting and reviewing safety information pertinent to FAAH inhibitors in US and will work with sponsors, patients, investigators to ensure safety