NEUROCRINE — Ingrezza FDA Summary Review (NDA/BLA 209241, 2017)
NEUROCRINE · 2017 · FDA Summary Review (Drugs@FDA) · company profile →
Report summary
The FDA review of valbenazine (Ingrezza) for Tardive Dyskinesia (TD) recommends approval, citing significant symptom reduction, particularly with the 80 mg/day dose. The report details trial designs, pharmacokinetics, and safety data. Key safety findings include somnolence, QT prolongation, and no increased suicidality. The review also covers regulatory decisions on labeling, risk management, and post-marketing requirements for valbenazine in TD treatment.
Key findings — cited to the page
| Somnolence rate | 4% | · p.29 |
| Suicidal ideation or behavior (Study 1201) | 3.7% | Study 1201 · p.30 |
| Suicidal ideation or behavior (Study 1201) | 1.8% | Study 1201 · p.30 |
| Suicidal ideation (Study 1202) | 5.9% | Study 1202 · p.30 |
| QTcF prolongation (valbenazine 160 mg vs placebo) | 11.7 ms | · p.31 |
| Anticholinergic effects | 4.9% | · p.32 |
| Anticholinergic effects | 5.5% | · p.32 |
| Application Number | 209241Orig1s000 | · p.1 |
| Breakthrough Status | granted | · p.7 |
| AIMS change from baseline | -3.2 | Study 1304 · p.17 |
| AIMS change from baseline vs placebo | -3.1 | Study 1304 · p.17 |
| Somnolence rate | 11% | · p.29 |
Source: NEUROCRINE ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Neurology library →