The U.S. Food and Drug Administration, with information received from the European Medicines Agency (EMA) and the French national medicines agency (ANSM), has completed a comprehensive review of safety information relevant to the investigational new drug BIA 10-2474 and the potential implications for related drugs under investigation in the U.S. The Agency has found, based on the available information, that BIA 10-2474 exhibits a unique toxicity that does not extend to other drugs in the class, called fatty acid amide hydrolase (FAAH) inhibitors.

There are no clinical trials with BIA 10-2474 underway in the U.S. The first phase 1 clinical trial of BIA 10-2474 was conducted in France in January, 2016, and resulted in the death of one enrolled subject and hospitalization of 5 others. Four of these 5 subjects experienced neurological injury.

Based on these findings, the FDA is working with sponsors to establish the appropriate path forward for FAAH inhibitors under investigation in the U.S. We are also working to ensure healthy subjects, patients, and investigators participating in FAAH inhibitor clinical trials are fully informed of the risks and potential benefits of these experimental therapies.

Posted on the FDA website on 12 August 2016