Lasmiditan (1) – Rayvow®

• Clinical trials
  • The studies presented in the dossier – LAHJ (SAMURAI), LAHK (SPARTAN) and LAIJ (CENTURION) studies presented in the dossier are randomised controlled trials comparing lasmiditan with placebo in the acute treatment of the headache phase of migraine attacks with or without aura.

Adults with migraine with or without aura who require acute treatment

• For adults with migraine with or without aura who require acute treatment, the additional benefit of lasmiditan is not proven.
• The pharmaceutical manufacturer has not provided any data for the assessment of the additional benefit of lasmiditan compared with the appropriate comparator therapy for adults with migraine, with or without aura, who require acute treatment.
• In accordance with the pharmaceutical manufacturer’s approach set out in the dossier, these studies are not taken into account for the present benefit assessment due to the lack of comparison with the appropriate comparator therapy.
• Overall assessment
  • An additional benefit of lasmiditan compared with the appropriate comparator therapy is not proven.

Courtesy translation only, please refer to the German original.