Teva’s experimental therapy for pediatric Tourette syndrome receives FDA priority review, accelerating potential approval timelines.
Teva Pharmaceuticals (TEVA) secured a priority review designation from the U.S. FDA for ecopipam, an investigational treatment for children with Tourette syndrome. The designation shortens the review period to six months from the standard ten months.
The therapy targets a neurodevelopmental condition affecting approximately 1 in 160 children in the U.S. No FDA-approved treatments currently exist for pediatric Tourette syndrome. Teva’s application follows positive clinical trial data submitted earlier this year.
Shares of TEVA showed modest gains in premarket trading following the announcement.