UCB SA — Lacosamide UCB EMA EPAR variation assessment report (EMEA/H/C/005243, 2019)
UCB SA · 2019 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes a Type II variation assessment for lacosamide (Vimpat) by the CHMP, focusing on updating the EU SmPC with data for neonates. Studies SP0968 and EP0223 investigated lacosamide's pharmacokinetics (PK), efficacy, and safety in neonatal seizures. While PK data were updated, the efficacy and safety findings were deemed insufficient to establish a positive benefit/risk balance for a new neonatal indication or dosing recommendations due to small sample sizes. No new significant safety concerns were identified, but definitive conclusions on efficacy and long-term neurodevelopmental outcomes remain limited. Regulatory updates to the SmPC will reflect the available data and acknowledge the insufficient evidence for a positive benefit/risk balance in neonates. Concerns regarding safety profile consistency and the classification of neonatal seizures were also addressed.
Key findings — cited to the page
| Percentage of participants experiencing severe TEAEs | 15.4 % | SP0968 · p.7 |
| Lacosamide EU approval for primary generalised tonic-clonic seizures (adjunctive) | 4 years age | Vimpat · EU · p.5 |
| Lacosamide EU approval for partial-onset seizures (monotherapy and adjunctive) | 2 years age | Vimpat · EU · p.5 |
| Total patients in PEDSnet database | 15239809 | EP0223 · p.6 |
| Neonates with AED administrations in first 28 days of life | 11956 | EP0223 · p.6 |
| Percentage of neonates with AED administrations in first 28 days of life | 0.078 % | EP0223 · p.6 |
| Eligible neonates for study EP0223 | 5680 | EP0223 · p.6 |
| Percentage of eligible neonates for study EP0223 | 0.037 % | EP0223 · p.6 |
| Neonates in lacosamide cohort (EP0223) | 103 | EP0223 · p.6 |
| Neonates in other AEDs cohort (EP0223) | 5577 | EP0223 · p.6 |
| Matched neonates in lacosamide cohort (EP0223) | 100 | EP0223 · p.6 |
| Matched neonates in other AEDs cohort (EP0223) | 567 | EP0223 · p.6 |
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 →