Udvalget vurderede, at fordelene ved Diacomit opvejer risiciene ved at anvende det i kombination med clobazam og valproat som tillægsbehandling mod refraktoriske, generaliserede tonisk- kloniske anfald hos patienter med SMEI (eller Dravets syndrom), hvis anfald ikke kan kontrolleres tilstrækkeligt med clobazam og valproat.
It decided that Diacomit’ s benefits are greater than its risks for use in conjunction with clobazam and valproate as adjunctive therapy of refractory generalised tonic-clonic seizures in patients with SMEI (or Dravet’ s syndrome) whose seizures are not adequately controlled with clobazam and valproate.