Lasmiditan: First Approval

Compliance with Ethical Standards

Funding: The preparation of this review was not supported by any external funding.

Conflict of interest: During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the author on the basis of scientific completeness and accuracy. Yvette Lamb is a salaried employee of Adis International Ltd/Springer Nature, is responsible for the article content and declares no relevant conflicts of interest.

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Abstract

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.