Takeda Pharmaceutical Company Limited — Trintellix FDA Review (NDA204447, SUPPL 20, 2020)
Takeda Pharmaceutical Company Limited · 2020 · FDA Review (openFDA) · company profile →
Report summary
This report summarizes the FDA's approval of Takeda's Trintellix (vortioxetine) for Major Depressive Disorder (MDD), including label updates based on a Phase 4 relapse prevention study (LuAA21004_402). This study demonstrated Trintellix's efficacy in prolonging time to relapse across 5mg, 10mg, and 20mg doses compared to placebo, fulfilling a postmarketing commitment. The report details Trintellix's safety profile, common adverse reactions, drug interactions, and use in specific populations. While the maintenance study found no new safety signals, postmarketing surveillance identified potential aggression and agitation, leading to label updates. The document also covers Trintellix's efficacy in various MDD populations, including cognitive function, and its mechanism of action.
Key findings — cited to the page
| User fee goal date | November 14, 2020 | · p.151 |
| Risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants | Increased | · p.9 |
| Approval Date | October 19, 2018 | TRINTELLIX · p.1 |
| Number of Subjects (SAFPOP) | 34 | LuAA21004_402 · USA · p.141 |
| Labeling Revision Date | 11/2020 | · p.9 |
| Study Type | Randomized, Double-Blind, Placebo-Controlled, Phase 4, Relapse Prevention Study | Lu AA21004-402 · p.4 |
| Postmarketing Commitment Fulfilled | 2084-6 | US · p.5 |
| Initial U.S. Approval | 2013 | TRINTELLIX · U.S. · p.9 |
| Indication | treatment of major depressive disorder (MDD) | TRINTELLIX · p.1 |
| Number of Subjects (SAFPOP) | 35 | LuAA21004_402 · USA · p.141 |
| Supplemental New Drug Application (sNDA) received date | January 14, 2020 | Trintellix (vortioxetine) Tablets · p.4 |
| Indication | treatment of major depressive disorder (MDD) in adults | TRINTELLIX · p.9 |
Source: Takeda Pharmaceutical Company Limited ↗ · 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 →