FYCOMPA (perampanel), antiepileptic
NEUROLOGY - New indication
Opinions on drugs - Posted on Jan 03 2017
Reason for request
Extension of indication
No clinical benefit demonstrated by comparison with other antiepileptics in the treatment of primary generalised tonic-clonic seizures in patients from 12 years of age with idiopathic generalised epilepsy
- FYCOMPA has Marketing Authorisation in the treatment of primary generalised tonic-clonic seizures in adults and adolescents aged 12 years and older with idiopathic generalised epilepsy, in combination with other antiepileptics.
- Without a comparative study, there was no demonstrable clinical benefit compared with other antiepileptics.
- The adverse effects are primarily neurological (vertigo, risk of fall) and psychiatric (irritability, aggression), some of which may be serious.
Clinical Added Value
|no clinical added value||
Évaluation des médicaments