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Reyvow FDA Approval History

Last updated by Judith Stewart, BPharm on July 27, 2020.

FDA Approved: Yes (First approved October 11, 2019)
Brand name: Reyvow
Generic name: lasmiditan
Dosage form: Tablets
Company: Eli Lilly and Company
Treatment for: Migraine

Reyvow (lasmiditan) is a serotonin (5-HT)1F receptor agonist indicated for the acute treatment of migraine with or without aura in adults.

  • Reyvow is the first in the new class of drugs called ditans (serotonin (5-HT)1F receptor agonists) which have potentially fewer vasoconstriction side effects compared to triptans.
  • Reyvow tablets are taken orally as needed. No more than one dose should be taken in 24 hours.
  • Reyvow causes central nervous system (CNS) depression and the results of clinical studies reported high rates of CNS related adverse reactions including dizziness and sedation. Patients taking Reyvow must be warned that the drug may cause significant driving impairment and they are advised not to drive or operate machinery for at least 8 hours after taking a dose. Patients who cannot follow this advice should not take Reyvow.
  • Common side effects include dizziness, fatigue, paresthesia ('pins and needles'), and sedation.
  • Lasmiditan will be scheduled under the Controlled Substances Act (DEA decision pending) due to its potential for abuse and dependence.

Development Timeline for Reyvow

DateArticle
Oct 11, 2019Approval  FDA Approves Reyvow (lasmiditan), the First Serotonin (5-HT) 1F Receptor Agonist for the Acute Treatment for Migraine
May  8, 2019AAN 2019: Two New Analyses of Lasmiditan Phase 3 Studies Measured Onset of Effect and the Effect of Lasmiditan in Patients with Prior Triptan Experience
Nov 14, 2018Lilly Submits New Drug Application to the FDA for Lasmiditan for Acute Treatment of Migraine
Sep  9, 2017Lilly's Lasmiditan Significantly Reduces Pain In Patients With Migraine
Aug  4, 2017Lilly Announces Positive Results For Second Phase 3 Study Of Lasmiditan For The Acute Treatment Of Migraine

Further information

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