Eptinezumab, Approved for Prevention of Migraine Now Commercially Available
Eptinezumab (Vyepti, Lundbeck, Deerfield, IL), the first and only intravenous treatment for migraine prevention, is now commercially available in the US and can be obtained via select specialty distributors and specialty pharmacies.
The efficacy and safety of eptinezumab was demonstrated in 2 phase 3 clinical trials, PROMISE 1 in episodic migraine (NCT02559895) and PROMISE 2 in chronic migraine (NCT02974153). Treatment with eptinezumab decreased mean monthly migraine days (MMD) over months 1 to 3 relative to placebo for both episodic and chronic migraine. Treatment benefit with eptinezumab vs placebo for both doses of eptinezumab (100 mg and 300 mg) was seen as early as day 1 post-infusion, A lower percentage of participants treated with eptinezumab experienced a migraine in the first 7 days than what seen with placeb.
“We are pleased to announce the availability of Vyepti for migraine prevention in the US, along with a suite of online resources for patients and their healthcare providers, which we hope will be useful to learn more about this new treatment option,” said Peter Anastasiou, Lundbeck’s executive vice president, North America. “Whilst we recognize and face the challenges of this global pandemic together, Lundbeck remains steadfast in our commitment to bring Vyepti to patients."
The safety of eptinezumab was evaluated in 2,076 participants with migraine who received at least 1 dose of eptinezumab. The most common adverse reactions (≥2% and at least 2% or greater than placebo) in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity. In PROMISE 1 and PROMISE 2, 1.9% of individuals treated with eptinezumab discontinued treatment due to adverse reactions.
Responding to challenges posed by COVID-19, the company has adjusted its launch activities to largely center on delivering content virtually, digitally, and socially, so patients and their healthcare providers are informed about this new treatment option. Eptinezumab was approved by the US Food and Drug Administration (FDA) on February 21, 2020, for the preventive treatment of migraine in adults.