FDA to Investigate French Trial With EU Regulators
Following the death of one subject and neurological injury to four others in a Phase 1 clinical trial in France, the FDA and European regulators are teaming up to find out what went wrong.
The trial — conducted by French clinical research organization Biotrial — was focusing on Portugal-based Bilal’s BIA 10-2474, an inhibitor of the fatty acid amide hydrolase. The FDA has said it will team up with the European Medicines Agency and French authorities to investigate.
There have been no clinical studies with BIA 10-2474 in the U.S., the FDA says. The agency adds that it is gathering and reviewing safety information regarding FAAH inhibitors under investigation in the U.S.