Perampanel (4) – Fycompa®

Epilepsy, focal seizures, ≥ 12 years, ≥ 4 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-604
ATC code N03AX22 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 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 partial-onset seizures (POS) with or without secondarily generalised seizures in patients from 4 to < 12 years of age.

 
Subpopulation Indication Comparator
Children aged 4 to < 12 years with focal seizures with or without secondary generalisation(s) in adjunct 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 Eslicarbazepine, gabapentin, lacosamide, lamotrigine, levetiracetam, oxcarbazepine, topiramate, valproic acid, zonisamide, brivaracetam taking into account the baseline and previous therapy(ies) and taking into account the reason for the change of 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

  • 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.

Associated procedures



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