Breaking New Ground in Migraine Prevention: Eptinezumab-jjmr

On February 21, 2020, the FDA approved eptinezumab-jjmr (Vyepti; Lundbeck) as the first intravenous migraine preventative treatment for adults. Administered via 30-minute infusion every 3 months at a 100 mg dose (some patients will benefit from 300 mg), eptinezumab-jjmr delivers rapid bioavailability and convenience compared to other therapies.¹

A single‑dose vial of eptinezumab-jjmr (Vyepti; Lundbeck) 100 mg/mL ready for intravenous infusion, representing the first and only IV migraine prevention therapy administered quarterly. | Image Credit: Serega | stock.adobe.com

Findings

Clinical evidence from the pivotal phase 3 trials PROMISE-1 (episodic migraine) and PROMISE-2 (chronic migraine) confirmed that eptinezumab-jjmr significantly reduces mean monthly migraine days (MMDs) between months 1 and 3 compared with placebo. In PROMISE-2, both the 100 mg and 300 mg doses yielded a 7.7-day and 8.2-day reduction in MMDs, compared to 5.6 days with placebo (p<0.0001). Remarkably, benefits emerged within 24 hours, and the percentage of patients experiencing migraines was lower with eptinezumab-jjmr during the first 7 days post-infusion.^1,2

The phase 4 RESOLUTION trial extended these findings to a challenging population: adults with chronic migraine and medication-overuse headache. In this randomized placebo-controlled study (n=608), participants receiving eptinezumab-jjmr achieved a 6.9-day reduction in MMDs over weeks 1 through 4, compared with a 3.7-day reduction with placebo. Acute medication use also declined substantially (-11.2 vs -7.8 days through week 12). Patient reported outcomes showed improvements in pain severity by week 2 and reductions in headache burden, disability, activity impairment, and work productivity loss.^1,2

Safety data from PROMISE-1, PROMISE-2, and RESOLUTION encompassing over 2000 patients indicated high tolerability. The most common adverse effects were nasopharyngitis and hypersensitivity reactions. Only 1.9% of participants discontinued due to adverse effects.^1,2

Conclusion

Pharmacists play a critical role in facilitating access, education, and continuity of care related to eptinezumab-jjmr. They can collect documentation on prior preventive therapies, baseline MMDs, and follow-up outcomes to support prior authorization, including site-of-care arrangements. Pharmacists also counsel patients on the advantages of intravenous delivery, such as 100% bioavailability, rapid onset, and monitoring for adverse effects like hypersensitivity. Furthermore, pharmacists can help track MMD reductions at 3-month intervals, collaborating with neurology and primary care teams to satisfy payer requirements and support long-term therapy adherence.^1-3

Eptinezumab-jjmr represents a transformative advance in migraine prevention with its rapid, sustained efficacy and strong safety profile. Pharmacists are instrumental in reducing administrative barriers, guiding patient education and infusion logistics, and ensuring durable treatment outcomes.^1,3

REFERENCES

1. FDA approves Lundbeck’s EPTINEZUMAB-JJMR™ (eptinezumab‑jjmr) — the first and only intravenous preventive treatment for migraine. News release. Lundbeck. February 21, 2020. Accessed July 2, 2025. https://www.lundbeck.com/us/newsroom/2020/fda-approves-lundbeck-s-vyepti---eptinezumab-jjmr----the-first-a

2. New data demonstrates robust efficacy of Eptinezumab-jjmr® (eptinezumab) in otherwise difficult-to-treat patients with severe migraine. News release. PR Newswire. June 21, 2025. Accessed July 2, 2025. https://www.prnewswire.com/news-releases/new-data-demonstrates-robust-efficacy-of-vyepti-eptinezumab-in-otherwise-difficult-to-treat-patients-with-severe-migraine-302487653.html

3. Aetna. Clinical Policy Bulletin 0970: Eptinezumab‑jjmr (Eptinezumab-jjmr). Updated November 13, 2024. Accessed June, 2025. https://www.aetna.com/cpb/medical/data/900_999/0970.html