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Vyepti FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 27, 2021.

FDA Approved: Yes (First approved February 21, 2020)
Brand name: Vyepti
Generic name: eptinezumab-jjmr
Dosage form: Injection
Company: Lundbeck Inc.
Treatment for: Migraine Prevention

Vyepti (eptinezumab-jjmr) is a calcitonin gene-related peptide antagonist indicated for the prevention of migraine in adults.

  • Vyepti is administered as an intravenous infusion over approximately 30 minutes, every 3 months.
  • Vyepti may cause serious hypersensitivity reactions. Patients should contact their healthcare provider immediately if they experience signs or symptoms of a hypersensitivity reaction such as angioedema, urticaria, facial flushing, or rash.
  • Common side effects include nasopharyngitis and hypersensitivity reactions. Most of the hypersensitivity reactions that occurred in clinical trials were not serious, but often led to discontinuation, or required treatment.

Development timeline for Vyepti

Feb 22, 2020Approval  FDA Approves Vyepti (eptinezumab-jjmr) Intravenous Injection for the Preventive Treatment of Migraine
Jun 27, 2017Alder BioPharmaceuticals Announces Positive Eptinezumab Phase 3 Results for Prevention of Frequent Episodic Migraine

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.