Lasmiditan: First Approval.

Lasmiditan (REYVOW™; Eli Lilly and Company) is an orally available serotonin (5-HT)1F receptor agonist. In October 2019, the US FDA approved lasmiditan 50 mg and 100 mg tablets for the acute treatment of migraine with or without aura in adults. Approval was based on positive results from two pivotal phase III trials, in which lasmiditan significantly improved the proportions of patients achieving freedom from headache pain and freedom from the most bothersome symptom (photophobia, phonophobia or nausea), relative to placebo, when used to treat a migraine with moderate to severe pain. Lasmiditan is not for use in the preventive treatment of migraine. This article summarizes the milestones in the development of lasmiditan leading to its first approval for the acute treatment of migraine in adults.