After anti-CGRP failure, Vyepti delivers in INFUSE study 75.7% report improvement, mean 6.8 fewer headache days from 20 baseline. Real-world evidence from 111 patients at HCOP 2026 conference
Written By: Pharmacally Medical News Desk
H. Lundbeck A/S announced six-month interim results from the ongoing 12-month INFUSE real-world study of Vyepti (eptinezumab) in adults with migraine who failed at least one prior preventive anti-CGRP therapy. Presented at the 2026 Headache Cooperative of the Pacific (HCOP) Annual Conference in California, the data show clear improvements in patient-reported outcomes for this high-burden group.
These findings fill a key evidence gap: real-world benefits of switching from subcutaneous or oral CGRP therapies to intravenous eptinezumab had been limited until now.
Clinical Evidence
The prospective, observational INFUSE study recruited U.S. adults with migraine through two Vyepti Infusion Network partners. Participants qualified after failing one or more preventive anti-CGRP treatments due to lack of efficacy or tolerability—no minimum washout period was required.
This interim analysis covers 111 participants who completed six months of eptinezumab treatment.
Key Effectiveness Results at Month 6
- 75.7% reported migraine improvement on the Patient Global Impression of Change (PGIC) scale.
- 44.1% felt “much improved” or “very much improved.”
- 44.1% achieved ≥50% reduction in monthly headache days.
- Mean monthly headache days dropped 6.8 days, from a baseline of 20.0 days.
- 26.1% saw >75% reduction in monthly headache days.
- Patients averaged 6.3 more “good days” per month versus baseline.
Safety data collection is observational, with adverse events tracked via standard post-marketing channels. From prior Phase 3 trials, eptinezumab shows good tolerability; common reactions include nasopharyngitis and hypersensitivity.
Johan Luthman, Executive Vice President and Head of Research & Development at Lundbeck, said the results “reinforce confidence in eptinezumab’s ability to reduce migraine burden outside controlled trials.” He noted consistent frequency reductions and better daily function, even after limited success with other CGRP options.
Regulatory Status
The FDA approved eptinezumab in February 2020 for adult migraine prevention. In January 2022, the European Commission authorized it for adults with ≥4 migraine days monthly. It’s now launched in over 30 global markets.
About Eptinezumab
This humanized monoclonal antibody binds CGRP for migraine prevention. Designed for IV infusion, it proved effective in Phase 3 PROMISE-1 (episodic migraine) and PROMISE-2 (chronic migraine) trials, cutting monthly migraine days with benefits starting as early as Day 1 post-infusion.
About Migraine
Migraine is a chronic neurological disorder with recurrent attacks, often with nausea, vomiting, photophobia, or phonophobia. It disrupts work, social life, and quality of life, ranking as a top disability cause under age 50. Without prevention, attacks worsen, leading to chronification and acute medication overuse.
References
Lundbeck presents new real-world data highlighting meaningful improvements in patients severely impacted by migraine initiating Vyepti® (eptinezumab), at HCOP Annual Conference, 30 January 2026, https://news.cision.com/h–lundbeck-a-s/r/lundbeck-presents-new-real-world-data-highlighting-meaningful-improvements-in-patients-severely-impa,c4298837