UCB SA — Briviact (in Italy: Nubriveo) EMA EPAR public assessment report (EMEA/H/C/003898, 2016)
UCB SA · 2016 · EMA EPAR public assessment report · company profile →
Report summary
This EMA EPAR report details the marketing authorization assessment for UCB Pharma SA's Briviact (brivaracetam) as adjunctive therapy for partial-onset seizures in epilepsy patients aged 16+. The report covers quality, manufacturing, and non-clinical studies, including pharmacokinetics, toxicology, and environmental risk. Clinical trials demonstrated Briviact's efficacy, showing significant reductions in seizure frequency and higher responder rates compared to placebo, with a dose-response relationship. Common adverse events included somnolence and dizziness. The CHMP concluded a favorable benefit-risk balance, classifying brivaracetam as a new active substance, and requested a risk management system modification.
Key findings — cited to the page
| Irritability in PBO group (Pool S1) | 1.1 % | · p.95 |
| Irritability in BRV Overall group (Pool S1) | 2.9 % | · p.95 |
| Irritability in BRV Overall group (Pool S1) | 2.9 % | · p.99 |
| Irritability in BRV 50mg/day group (Pool S1) | 5.0 % | · p.99 |
| Irritability in PBO group (Pool S1) | 1.1 % | · p.99 |
| NOEC for Daphnia sp. Reproduction Test | 100 mg/L | Brivaracetam · p.33 |
| neutrophil count Grade 3 | 5.7 % | · p.102 |
| neutrophil count decreased (NCI Grade 3) | 4 subjects | · p.111 |
| decrease in neutrophils meeting NCI Grade 2 criteria | 47.2 % | · p.102 |
| Convulsion in BRV Overall group (Pool S1) | 2.5 % | · p.96 |
| Anxiety in PBO group (Pool S1) | 1.3 % | · p.96 |
| Convulsion in PBO group (Pool S1) | 1.5 % | · p.96 |
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 →