Vanda Pharmaceuticals Inc. — Hetlioz EMA EPAR public assessment report (EMEA/H/C/003870, 2015)
Vanda Pharmaceuticals Inc. · 2015 · EMA EPAR public assessment report · company profile →
Report summary
Hetlioz (tasimelteon) by Vanda Pharmaceuticals was approved for Non-24-Hour Sleep-Wake Disorder in totally blind adults, following its orphan medicinal product designation. Non-clinical studies demonstrated tasimelteon's potent MT1/MT2 receptor agonist activity, favorable pharmacokinetic profile, and good safety margin. Comprehensive toxicology studies, including repeat-dose, genotoxicity, and carcinogenicity, showed no clinically relevant concerns. Clinical trials (SET and RESET) confirmed its efficacy in entraining circadian rhythms and maintaining treatment effects, demonstrating superiority over placebo. Common adverse events included headache and somnolence, with no significant safety signals. The Risk Management Plan addressed safety concerns, and the overall benefit-risk balance was positive, leading to marketing authorization.
Key findings — cited to the page
| Marketing Authorisation date | 31 January 2014 | Hetlioz · United States · p.8 |
| CHMP positive opinion date for Marketing Authorisation | 23 April 2015 | Hetlioz · European Union · p.9 |
| Marketing Authorisation application submission date | 1 May 2014 | Hetlioz · European Union · p.7 |
| Missing Information | Off label use | · p.70 |
| Study Type | Phase III study | VP-VEC-162-3202 · p.70 |
| Study Duration | 1-year | VP-VEC-162-3202 · p.70 |
| Dose Regimen | 20 mg/night | VP-VEC-162-3202 · p.70 |
| Study Type | Phase III study | VP-VEC-162-3204 · p.71 |
| Study Duration | 24-month | VP-VEC-162-3204 · p.71 |
| Dose Regimen | 20 mg/night | VP-VEC-162-3204 · p.71 |
| Orphan medicinal product designation date | 23 February 2011 | Hetlioz · European Union · p.7 |
| Number of dose-finding clinical studies for tasimelteon | 2 | · p.41 |
Source: Vanda Pharmaceuticals Inc. ↗ · 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 →