Teva — Austedo EMA EPAR public assessment report (EMEA/H/C/006371, 2026)
Teva · 2026 · EMA EPAR public assessment report · company profile →
Report summary
The EMA's assessment of Teva's Austedo (deutetrabenazine) for moderate to severe tardive dyskinesia (TD) concluded with a positive opinion for marketing authorization. Deutetrabenazine, a deuterated derivative of tetrabenazine, demonstrated statistically significant improvements in Abnormal Involuntary Movement Scale (AIMS) scores in Phase 3 trials (C-18, C-23), with long-term efficacy shown in study C-20. The safety profile was generally well-tolerated, with common adverse events including somnolence, anxiety, and depression, and a low discontinuation rate. Non-clinical and clinical data highlighted improved pharmacokinetic properties and a comparable safety profile to tetrabenazine, though the New Active Substance (NAS) status was debated due to insufficient evidence of clinically meaningful safety differences. The risk management plan and pharmacovigilance system were deemed acceptable.
Key findings — cited to the page
| Number of centers | 41 | SD-809-C-18 · United States, Poland, Slovakia, Czech Republic · p.81 |
| Age range of participants | 18 to 75 years | SD-809-C-18 · p.81 |
| Randomization ratio | 1:1 | SD-809-C-18 · p.81 |
| Maintenance period duration | 6 weeks | SD-809-C-18 · p.81 |
| Planned enrollment | 92 patients | SD-809-C-18 · p.81 |
| Patients analyzed for efficacy and safety | 117 patients | SD-809-C-18 · p.81 |
| Trial phase | Phase 2/3 | SD-809-C-18 · p.81 |
| Minor metabolites M1 and M4 VMAT2 affinities | 63-fold lower | · p.24 |
| Therapeutic indication | treatment of moderate to severe tardive dyskinesia in adults | Austedo · p.15 |
| Titration period duration | 6 weeks | SD-809-C-18 · p.81 |
| Deutetrabenazine molar mass | 323.462 g/mol | · p.15 |
| Minimum duration of DRA use | 3 months | SD-809-C-18 · p.81 |
Source: Teva ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Neurology library →