U.S. FDA Accepts Teva’s New Drug Application (NDA) and Grants Priority Review for Ecopipam, a First-in-Class Investigational Therapy for Pediatric Patients with Tourette Syndrome
Teva Pharmaceutical Industries announced that the FDA accepted the New Drug Application for ecopipam and granted Priority Review for the treatment of pediatric Tourette syndrome. The application is supported by positive Phase 2b and Phase 3 data, including a Phase 3 study showing a 53% decreased risk of relapse compared to placebo.
Key figures
- Drug Name
- Ecopipam (EBS-101)
- Phase Of Trial
- Phase 3
- P value
- 0.008
- Pdufa date
- Late in the first quarter of 2027
- Orphan drug
- Yes
- Priority review
- Yes
- Relapse risk reduction
- 53%
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