FDA Grants Priority Review to Teva's Ecopipam for Pediatric Tourette Syndrome

Teva Pharmaceutical Industries said Wednesday that the U.S. Food and Drug Administration accepted its New Drug Application for ecopipam and granted it Priority Review, with a targeted decision date late in the first quarter of 2027. The regulator also granted the investigational therapy Orphan Drug designation for pediatric patients with Tourette syndrome. Ecopipam is a first-in-class selective antagonist that blocks dopamine signaling at the D1 receptor. A Phase 3 trial found pediatric responders had a 53 percent lower risk of relapse over 12 weeks than those given placebo. Teva said that if approved it would be the first new Tourette treatment for children in more than a decade.