The FDA accepted Teva Pharmaceutical Industries’ New Drug Application for ecopipam. The agency granted the investigational, first-in-class pediatric Tourette syndrome therapy Priority Review.
If approved, ecopipam would be the first new treatment for this patient group in over a decade. The FDA set a target action date for late in the first quarter of 2027.
Positive data from Phase 2b and Phase 3 clinical trials support the application. This development advances Teva’s Pivot to Growth strategy centered on neuroscience expertise.