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VIMPAT (lacosamide), antiepileptic

NEUROLOGY - New indication
Opinions on drugs - Posted on Jul 19 2018

Reason for request

Extension of indication

 High clinical benefit but no proven clinical added value, as monotherapy, for the therapeutic strategy of partial-onset seizures with or without secondary generalisation, for adults and adolescents with epilepsy.

  • VIMPAT has now been granted, in addition to the marketing authorisation for combination therapy, a marketing authorisation for monotherapy treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents (16-18 years) and children over 4 years with epilepsy.
  • Its non-inferiority has been demonstrated compared to carbamazepine LP in terms of efficacy, on the rate of seizure-free patients over a 6-month period.
  • No robust data are available inferring superior safety of lacosamide compared to other antiepileptic treatments.
  • In monotherapy treatment, it is now an alternative first-line option.


Clinical Benefit



Clinical Added Value

no clinical added value


Therapeutic use


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