UCB SA — Fintepla EMA EPAR variation assessment report (EMEA/H/C/003933, 2020)
UCB SA · 2020 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes a retrospective cohort study (RWE1609) using US claims data to assess mortality in Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS) patients. The study found significant mortality burdens in both conditions, with LGS consistently exhibiting higher rates (14.2 per 1000 patient-years) than DS (7.3 per 1000 patient-years). Mortality increased with age and healthcare resource utilization severity in both groups. DS patients, especially pediatric, showed substantially elevated standardized mortality ratios compared to the general population. Key risk factors for increased mortality included medical complexity and functional impairment.
Key findings — cited to the page
| Standardised mortality ratio (DS, HCRU Q4) | 18.5 | United States · p.16 |
| Mortality rate (DS, HCRU Q1) | 4.3 per 1000 PY | United States · p.14 |
| Standardised mortality ratio (DS, adults) | 3.4 | United States · p.16 |
| Standardised mortality ratio (DS, HCRU Q1) | 2.6 | United States · p.16 |
| Mortality rate (DS, adults) | 9.1 per 1000 PY | United States · p.14 |
| Mortality rate (DS, paediatric) | 6.7 per 1000 PY | United States · p.14 |
| Standardised mortality ratio (DS, overall) | 8.3 | United States · p.16 |
| Standardised mortality ratio (DS, paediatric) | 27.3 | United States · p.16 |
| Standardised mortality ratio (DS, low HCRU severity) | 3.9 | United States · p.16 |
| Standardised mortality ratio (DS, high HCRU severity) | 16.1 | United States · p.16 |
| Mortality rate | 7.3 per 1000 PY | United States · p.14 |
| Mortality rate (DS, HCRU Q4) | 10.5 per 1000 PY | United States · p.14 |
Source: UCB SA ↗ · 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 Neurology library →