Brivaracetam (3) – Briviact®
Focal seizures in epilepsy, additional therapy, 2 to < 4 years
Characteristics
| Start date | 01.03.2022 – Marketing authorisation: 24.02.2022 |
|---|---|
| Resolution | 01.09.2022 |
| INN | Brivaracetam |
| Brand name | Briviact® |
| Pharm. company | UCB Pharma GmbH |
| G-BA Procedure ID | D-791 |
| ATC code | N03AX23 Other antiepileptics (N03AX) |
| ICD-10 codes (AIS) | G40.08, G40.09, G40.1Attacks without alteration of consciousness, G40.2Attacks with alteration of consciousness, often with automatisms, G40.8Epilepsies and epileptic syndromes undetermined as to whether they are focal or generalized |
| Alpha-ID codes (AIS) | I3557Focal epilepsy, I85633Epilepsy, undetermined whether focal or generalized, I90702Focal onset of epileptic seizure, I91470Epilepsy with complex focal seizure, I91514Idiopathic localization-related epilepsy |
| DDD | 0.1 g O |
| Therapeutic area | Nervous system diseases Epilepsy, Epilepsy in children (Dravet syndrome / Lennox-Gastaut syndrome) |
| Reason for procedure | New therapeutic indication |
| Specialty | Combination therapy |
| Therapeutic indication of the resolution |
|---|
|
Adjunctive treatment of focal seizures with or without secondary generalization in children 2 to < 4 years of age with epilepsy. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Children aged 2 to < 4 years with focal epileptic seizures with or without secondary generalisation in adjunctive therapy | A patient-individual additional antiepileptic therapy, as far as medically indicated and if in each case no pharmacoresistance (in the sense of an insufficient response), intolerance or contraindication is known, taking into account the basic and (previous) therapy(s) and taking into account the reason for the change in therapy as well as any accompanying side effects |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (N01266) |
|---|---|
|
Study design
(best subpopulation) |
Single-arm + no comparison |
|
Meta analysis
(best subpopulation) |
no |
- Clinical trials
- Study N01263 is a single-arm Phase 2a study investigating the pharmacokinetics, safety and efficacy of brivaracetam in children and adolescents with epilepsy.
- Study EP0065 is a single-arm Phase 2 study investigating the pharmacokinetics and safety of brivaracetam administered as a 15-minute infusion and bolus infusion in children and adolescents with epilepsy.
- Study N01266 is a long-term Phase 3 clinical development study which, amongst others, included children and adolescents who had previously taken part in other studies with brivaracetam.
Children aged 2 to < 4 years with focal epileptic seizures, with or without secondary generalisation, as adjunctive therapy
- The additional benefit is not proven.
- No relevant RCT was identified for the assessment of additional benefit in which brivaracetam was compared with the appropriate comparator therapy.
- The pharmaceutical manufacturer therefore submits the non-comparative single-arm study N01266 on brivaracetam.
- As the single-arm study N01266 does not allow for a direct comparison of brivaracetam with the appropriate comparator therapy, the data are not suitable for assessing the additional benefit of brivaracetam.
- Furthermore, only four patients in study N01266 meet the criteria for the intended therapeutic indication in terms of age and seizure type.
Courtesy translation only, please refer to the German original.
Associated procedures
| Brivaracetam (3) | Briviact® | UCB Pharma GmbH | Focal seizures in epilepsy, additional therapy, 2 to < 4 years | 300–1,800 | 100% additional benefit not proven | |
| Brivaracetam (2) | Briviact® | UCB Pharma GmbH | Epilepsy, focal seizures, add-on therapy, 4 to < 16 years | 5,000–10,000 | 100% additional benefit not proven | |
| Brivaracetam (1) | Briviact® | UCB Pharma GmbH | Epilepsy, focal seizures, ≥ 16 years | 86,000–200,000 | 100% additional benefit not proven |
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