Perampanel (5) – Fycompa®

Epilepsy, primary generalised seizures, ≥ 12 years, ≥ 7 years to < 12 years

Characteristics

Start date 15.12.2020 – Marketing authorisation: 10.11.2020
Resolution 03.06.2021
INN Perampanel
Brand name Fycompa®
Pharm. company Eisai GmbH
G-BA Procedure ID D-634
ATC code N03AX22 Other antiepileptics (N03AX)
ICD-10 codes (AIS) G40.3Generalized idiopathic epilepsy and epileptic syndromes, G40.6, G40.8Epilepsies and epileptic syndromes undetermined as to whether they are focal or generalized
Alpha-ID codes (AIS) I25642Generalized epilepsy, I3587Grand mal seizure, I85633Epilepsy, undetermined whether focal or generalized
DDD 8 mg O
Therapeutic area Nervous system diseases Epilepsy, Epilepsy in children (Dravet syndrome / Lennox-Gastaut syndrome)
Reason for procedure New therapeutic indication
Specialty Bundling Patent/data protection expired

Therapeutic indication of the resolution

Fycompa (perampanel) is indicated for the adjunctive treatment of primary generalised tonic-clonic (PGTC) seizures in patients from 7 to < 12 years of age and older with idiopathic generalised epilepsy (IGE).
Subpopulation Indication Comparator
Children aged 7 to < 12 years with idiopathic generalised epilepsy and primary generalised tonic-clonic seizures in adjunctive therapy. Patient-specific additional antiepileptic therapy, if medically indicated and if no pharmacoresistance (in the sense of an insufficient response), intolerance or contraindication is known in each case, under selection of clobazam, lamotrigine, topiramate, valproic acid taking into account the baseline and previous therapy(ies) and considering the reason for the change in therapy as well as any associated side effects.

Studies and Results

No. of studies
(best subpopulation) 		2 (E2007-G000-311, E2007-G000-232)
Study design
(best subpopulation) 		Single-arm + other comparison
Meta analysis
(best subpopulation) 		no

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.

Associated procedures



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