Idorsia Ltd — Quviviq EMA EPAR public assessment report (EMEA/H/C/005634, 2022)
Idorsia Ltd · 2022 · EMA EPAR public assessment report · company profile →
Report summary
This EMA assessment report details the regulatory approval of Idorsia's QUVIVIQ (daridorexant) for insomnia. Daridorexant, a dual orexin receptor antagonist, demonstrated significant and clinically relevant improvements in sleep parameters (WASO, LPS, TST) at the 50mg dose in pivotal Phase 3 studies, with sustained efficacy and no significant withdrawal or rebound effects. Non-clinical studies confirmed its mechanism, low abuse potential, and favorable safety profile. While primarily metabolized by CYP3A4, dose adjustments are generally not needed for age or renal impairment. Safety assessments revealed mostly mild to moderate adverse events, with no major concerns in special populations, though potential for abuse and suicidal ideation in high-risk patients necessitates risk minimization. Overall, a positive benefit-risk balance was concluded for chronic insomnia.
Key findings — cited to the page
| Daphnia reproduction Test (NOEC) | 1 mg free base/L | Daridorexant · p.31 |
| safety margin for male and female reproduction in rats (free AUC) | >30 fold | Daridorexant · p.26 |
| NOAEL for male reproduction in rats | 450 mg/kg/day | Daridorexant · p.26 |
| NOAEL for female reproduction in rats | 100 mg/kg/day | Daridorexant · p.26 |
| Daphnia reproduction Test (EC10) | 1.8 mg free base/L | Daridorexant · p.31 |
| sTST improvement of at least 55 minutes from baseline at Month 3 | 48.4 % | Study 301 · p.84 |
| sTST improvement of at least 55 minutes from baseline at Month 3 | 41.1 % | Study 301 · p.84 |
| Subjects exposed to placebo | 729 | · p.109 |
| EMA/CHMP eligibility agreement date | 30 April 2020 | QUVIVIQ · European Union · p.5 |
| Marketing authorisation application submission date | 2 March 2021 | QUVIVIQ · European Union · p.5 |
| CHMP positive opinion for marketing authorisation date | 24 February 2022 | QUVIVIQ · European Union · p.6 |
| sTST improvement of at least 55 minutes from baseline at Month 3 (placebo) | 36.7 % | Study 301 · p.84 |
Source: Idorsia Ltd ↗ · 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 Psychiatry library →