NEUROCRINE — Ingrezza FDA Review (NDA/BLA 209241, 2022)
NEUROCRINE · 2022 · FDA Review (Drugs@FDA) · company profile →
Report summary
This report summarizes the FDA approval of Neurocrine Biosciences' Ingrezza (valbenazine) for adult tardive dyskinesia. It details the drug's indication, dosage, administration, warnings, precautions, and drug interactions, particularly for patients with hepatic impairment, CYP2D6 poor metabolizers, and those on strong CYP3A4 or CYP2D6 inhibitors. Clinical pharmacology findings addressed post-marketing commitments, revealing a significant increase in the active metabolite NBI-98782 with strong CYP2D6 inhibitors, necessitating a dose reduction. Severe renal impairment had no clinically meaningful impact. Labeling negotiations, finalized by March 31, 2020, incorporated these findings, especially regarding dosage recommendations for CYP2D6 poor metabolizers and drug interactions.
Key findings — cited to the page
| Headache incidence (INGREZZA) | 3.4 % | INGREZZA · p.12 |
| Indication | treatment of adults with tardive dyskinesia | INGREZZA (valbenazine) · p.1 |
| Approval Date | April 09, 2020 | INGREZZA (valbenazine) · p.1 |
| Revision Date | 04/2020 | · p.9 |
| Initial dosage | 40 mg once daily | INGREZZA · p.9 |
| Recommended dosage | 80 mg once daily | INGREZZA · p.9 |
| Recommended dosage for moderate or severe hepatic impairment | 40 mg once daily | INGREZZA · p.9 |
| Recommended dosage for known CYP2D6 poor metabolizers | 40 mg once daily | INGREZZA · p.9 |
| Initial dosage | 40 mg once daily | INGREZZA · p.10 |
| Recommended dosage | 80 mg once daily | INGREZZA · p.10 |
| Recommended dosage for moderate or severe hepatic impairment | 40 mg once daily | INGREZZA · p.10 |
| Recommended dosage for known CYP2D6 poor metabolizers | 40 mg once daily | INGREZZA · p.10 |
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 →