Lundbeck has announced that eptinezumab-jjmr (Vyepti, Lundbeck), the first and only intravenous (IV) treatment for migraine prevention, is now commercially available in the United States and can be obtained via select specialty distributors and specialty pharmacies.

“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. While we recognize and face the challenges of this global pandemic together, Lundbeck remains steadfast in our commitment to bring Vyepti to patients,” said Peter Anastasiou, executive vice president of Lundbeck’s North American branch, in a press release.

Responding to challenges posed by the coronavirus disease 2019 (COVID-19) pandemic, the company has adjusted its launch activities to largely center on delivering content virtually, digitally, and socially, so that patients and their health care providers are informed about the new treatment option, according to the press release. Eptinezumab-jjmr was approved by the FDA in February for the preventive treatment of migraines in adult patients.

The efficacy and safety of eptinezumab-jjmr was demonstrated in 2 phase 3 clinical trials (PROMISE 1 in episodic migraine and PROMISE 2 in chronic migraine). Eptinezumab-jjmr met its primary endpoint of decrease in mean monthly migraine days over months 1-3 in both episodic and chronic migraines.

The clinical trial program demonstrated a treatment benefit over placebo that was observed for both doses of eptinezumab-jjmr (100 mg and 300 mg) as early as day 1 post-infusion. The percentage of patients experiencing a migraine was lower for participants who received eptinezumab-jjmr than participants who received placebo for most of the first 7 days.

The safety of eptinezumab-jjmr was evaluated in 2076 patients with migraine who received at least 1 dose of eptinezumab-jjmr. The most common adverse events in the clinical trials for the preventative treatment of migraine were nasopharyngitis and hypersensitivity. In PROMISE 1 and PROMISE 2, 1.9% of patients treated with eptinezumab-jjmr discontinued treatment due to adverse reactions.

Reference
  1. Lundbeck’s VYEPTI™ (eptinezumab-jjmr), Quarterly Treatment for Migraine Prevention in Adults, Now Available in U.S. [news release]. Deerfield, IL. Businesswire website. Published April 6, 2020. https://www.businesswire.com/news/home/20200406005133/en/Lundbeck%E2%80%99s-VYEPTI%E2%84%A2-eptinezumab-jjmr-Quarterly-Treatment-Migraine-Prevention. Accessed April 6, 2020.