Investigational drugs in the USA related to BIA 10-2474 do not pose similar safety risks, says FDA

The US 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 USA.

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 USA. The first Phase I 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 five others. Four of these five subjects experienced neurological injury.