Perampanel (4) – Fycompa®

• Clinical trials
  • In the E2007-G000-311, 180 children with epilepsy aged between 4 and <12 years who had focal or generalised seizures were studied; despite their previous anti-epileptic treatment, they had experienced at least one focal or primary generalised tonic-clonic seizure in the 12 weeks prior to the start of the treatment phase.
  • In the E2007-G000-232 study, children aged 2 to <12 years with a diagnosis of epilepsy, regardless of subtype, were studied; these children had experienced at least one seizure in the four weeks prior to the start of the treatment phase despite their previous antiepileptic therapy.

Children aged 4 to <12 years with focal seizures, with or without secondary generalisation, as adjunctive therapy

• For children aged 4 to <12 years with focal seizures, with or without secondary generalisation, as adjunctive therapy, the additional benefit is not proven.
• The single-arm studies E2007-G000-311 and E2007-G000-232 were submitted for the assessment of the additional benefit of perampanel.
• As study E2007-G000-311 does not compare perampanel with the appropriate comparator therapy, it cannot be used to assess 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.
• Overall, no comparative data against the appropriate comparator therapy were presented.
• An additional benefit of perampanel compared with the appropriate comparator therapy is therefore not proven.
• As part of the benefit assessment, the two single-arm studies E2007-G000-311 and E2007-G000-232 on perampanel were submitted.
• No comparative data are available for perampanel as adjunctive therapy in children aged 4 to <12 years with focal seizures, with or without secondary generalisation, compared with the appropriate comparator therapy (patient-specific adjunctive antiepileptic therapy).
• An additional benefit is therefore not proven.
• Taking into account the available evidence on the medical benefit of perampanel, the severity of the condition and the statements from medical societies regarding the current reality of care, perampanel may represent a relevant treatment option in individual cases for children aged 4 to <12 years with focal seizures with or without secondary(r) generalisation as adjunctive therapy in individual cases.

Courtesy translation only, please refer to the German original.