The FDA has approved Lundbeck’s Vyepti (eptinezumab-jjmr) for the prevention of migraines in adults.
The approval was based on the results of two phase 3 clinical trials, in which Vyepti demonstrated a benefit over placebo as early as one day post-infusion. The percentage of patients experiencing a migraine was lower for Vyepti than with placebo for most of the first seven days of treatment.
Vyepti is the first intravenous preventative treatment for migraine. Lundbeck will launch the product in April.