Perampanel (3) – Fycompa®

Epilepsy, primary generalised seizures, ≥ 12 years

Characteristics

Start date 01.12.2017 – Marketing authorisation: 22.06.2015
Resolution 17.05.2018
INN Perampanel
Brand name Fycompa®
Pharm. company Eisai GmbH
G-BA Procedure ID D-325
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
Reason for procedure New therapeutic indication
Specialty 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 12 years of age and older with idiopathic generalised epilepsy (IGE).
Subpopulation Indication Comparator
Adults and adolescents aged 12 years and over with idiopathic generalised epilepsy with primary generalised tonic-clonic seizures (add-on therapy). Patient-specific add-on antiepileptic therapy with one of the following agents: Lamotrigine, levetiracetam, valproic acid, topiramate, clobazam. The therapy should be chosen by the doctor depending on the basic and previous therapy(ies) and taking into account the reason for the change in therapy and any associated side effects.

Studies and Results

No. of studies
(best subpopulation) 		1 (Studie 332) 0 (Data not accepted)
Study design
(best subpopulation) 		Data not accepted (Dossier: H2H vs. ACT)

  • Clinical trials
    • To assess the additional benefit, the pharmaceutical manufacturer has submitted randomised controlled trial 332.

Primary generalised tonic-clonic seizures in adults and adolescents aged 12 years and over with idiopathic generalised epilepsy

  • The additional benefit is not proven.
  • In summary, no data are available for the assessment of additional benefit.
  • Consequently, patients in the control arm of the study did not receive individualised add-on therapy, selected by the doctor, with any of the active ingredients (INNs) specified in the appropriate comparator therapy.
  • Consequently, there are no relevant data on perampanel in comparison with the appropriate comparator therapy that can be used to infer any additional benefit.

Courtesy translation only, please refer to the German original.

Associated procedures



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