Perampanel (5) – Fycompa®

Children aged 7 to <12 years with idiopathic generalised epilepsy and primary generalised tonic-clonic seizures as adjunctive therapy

• For children aged 7 to <12 years with idiopathic generalised epilepsy and primary generalised tonic-clonic seizures receiving adjunctive therapy, the additional benefit is not proven.
• An additional benefit of perampanel compared with the appropriate comparator therapy is therefore not proven.
• Perampanel may represent a relevant treatment option in individual cases for children aged 7 to <12 years with idiopathic generalised epilepsy and primary generalised tonic-clonic seizures as adjunctive therapy.
• The single-arm studies E2007-G000-311 and E2007-G000-232 were submitted for the assessment of the additional benefit of perampanel.
• As there is no comparison of perampanel with the appropriate comparator therapy, study E2007-G000-311 cannot be used to assess the additional benefit.
• As the study does not provide data for a comparison of perampanel with the appropriate comparator therapy and, furthermore, the four-week maintenance phase is clearly too short, this study cannot be used to assess the additional benefit either.
• Comparative data – including data to assess the safety profile – would be desirable, particularly in the vulnerable patient population of children aged 7 to < 12 years.
• Even though the EMA granted marketing authorisation for children aged 7 to < 12 years on the basis of an extrapolation of pharmacokinetic/pharmacodynamic data, no additional benefit can be extrapolated from adults to children in the present benefit assessment procedure, as the benefit assessment procedure for adults (Decision date: 17 May 2018) no additional benefit was identified because no evaluable data were available.
• Summary of the assessment
  • As part of the benefit assessment, the two single-arm studies E2007-G000-311 and E2007-G000-232 on perampanel were submitted.
  • No data are available for perampanel as an adjunctive therapy in children aged 7 to <12 years with idiopathic generalised epilepsy and primary generalised tonic-clonic seizures, compared with the appropriate comparator therapy (patient-specific adjunctive antiepileptic therapy).
  • An additional benefit is therefore not proven.

Courtesy translation only, please refer to the German original.