FDA Conferring With EU Counterparts on Trial Fiasco in France
Posted 22 January 2016 | By
The U.S. Food and Drug Administration (FDA) announced Friday that it is conferring with European regulators, including the European Medicines Agency (EMA) and France's ANSM, after a Phase I trial resulted this week in the death of one enrolled subject and neurological injury to four others.
FDA says no trials have occurred in the US with Bial’s BIA 10-2474, an inhibitor of fatty acid amide hydrolase (FAAH), an enzyme involved in cell function in the nervous system. That double-blind, randomized, placebo-controlled combined single-ascending dose and multiple ascending dose trial, which is currently under French investigation with the help of EMA, was conducted by clinical research organization Biotrial. The trial protocol was released yesterday by French newspaper Le Figaro.
“FAAH inhibitors have been studied for their potential therapeutic use in a number of neurological disorders,” FDA said. “This week’s tragedy in France is the first human fatality following exposure to an FAAH inhibitor.”
FDA also said it is in the process of collecting and reviewing safety information pertinent to FAAH inhibitors under investigation in the US. Janssen announced earlier this week that it would voluntarily suspend an FAAH Phase II trial for mood disorders, though the company has “not received any reports of serious adverse events.”
For its part, FDA will work with sponsors to ensure the safety of participants in clinical studies and take regulatory action as appropriate, and that patients and investigators participating in trials of FAAH inhibitors are fully informed of the risks and potential benefits of these drugs.
The agency also makes clear that Biotrial’s mishap is extremely rare in the US, as trial sponsors must “collect rigorous laboratory and animal data and must submit such safety data to FDA in an IND [investigational new drug] application before any human volunteers may be enrolled in a phase 1 study.” Sponsors also have to wait 30 days after submitting an IND application before Phase I studies can begin so FDA scientists can review the safety data and determine if the proposed study is reasonably safe to proceed.
“Catastrophic adverse events in phase 1 studies conducted in the U.S. are extremely rare,” the agency concluded.