VIMPAT (lacosamide), antiepileptic
Reason for request
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 Added Value
|no clinical added value||