Neurocrine Biosciences, Inc. — Ingrezza FDA Review (NDA209241, SUPPL 16, 2020)
Neurocrine Biosciences, Inc. · 2020 · FDA Review (openFDA) · company profile →
Report summary
The FDA approved Neurocrine Biosciences' Ingrezza (valbenazine) capsules on April 9, 2020, for adult tardive dyskinesia, based on supplemental NDA S-016. This approval incorporated revisions to the prescribing information, addressing postmarketing study findings. Key updates include dosage adjustments for patients on strong CYP2D6 inhibitors due to increased active metabolite exposure, and clarification that severe renal impairment does not necessitate dose changes. The review also confirmed no significant CYP2B6 induction by a valbenazine metabolite. Warnings regarding somnolence, QT prolongation, and parkinsonism were maintained. The FDA and Neurocrine Biosciences successfully negotiated labeling changes, leading to the approval of the supplemental application and fulfillment of postmarketing requirements.
Key findings — cited to the page
| Somnolence incidence (placebo) | 4.2% | · p.12 |
| Anticholinergic effects incidence (INGREZZA) | 5.4% | · p.12 |
| Somnolence incidence (INGREZZA) | 10.9% | · p.12 |
| sNDA received date | August 29, 2019 | Ingrezza (valbenazine) capsules · p.4 |
| Approval Date | April 09, 2020 | INGREZZA · p.1 |
| Indication | treatment of adults with tardive dyskinesia | INGREZZA · p.1 |
| Arthralgia incidence (placebo) | 0.5% | · p.12 |
| Incidence of parkinson-like adverse events | 3% | · p.11 |
| Incidence of parkinson-like adverse events (placebo) | <1% | · p.11 |
| Discontinuation due to adverse reactions (INGREZZA) | 3% | · p.12 |
| Discontinuation due to adverse reactions (placebo) | 2% | · p.12 |
| Anticholinergic effects incidence (placebo) | 4.9% | · p.12 |
Source: Neurocrine Biosciences, Inc. ↗ · 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 Psychiatry library →