- New 12-month data from the INFUSE study show patient-reported outcomes related to multiple migraine-related cognitive symptoms in participants who failed at least one prior calcitonin gene-related peptide (CGRP)-targeted therapy1
- Six-month data from the INFUSE study was recently published in Cephalalgia Reports, an official journal of the International Headache Society
- New PROCEED phase 2b route of administration and dose-finding trial results of bocunebart (Lu AG09222; anti-PACAP mAb) being investigated in migraine prevention2
DEERFIELD, Ill.--(BUSINESS WIRE)--Lundbeck US, the US subsidiaries of H. Lundbeck A/S., today announced the presentation of new VYEPTI® (eptinezumab-jjmr) data at the American Headache Society’s (AHS) 68th Annual Scientific Meeting, taking place June 4-7, 2026, in Orlando, Florida. The presentations will share findings from the INFUSE, DELIVER, SUNSET, and RESOLUTION trials, featuring real-world data and phase 3 clinical trial post-hoc analyses of VYEPTI and patient-reported outcomes on headache hours, brain fog and other cognitive symptoms, and dose escalation. New phase 2b data on bocunebart, an investigational drug targeting Pituitary Adenylate Cyclase-Activating Polypeptide (PACAP) for the prevention of migraine, will also be presented.
“To truly raise the bar and optimize outcomes for migraine care, we must continue to focus on what patients report are meaningful to them,” said Damian Fiore, Vice President, US Medical Affairs, Neurology at Lundbeck. “These data reinforce the importance of looking beyond headache days to the broader burden of migraine and the sustained impact preventive treatment may have over time.”
VYEPTI is indicated for the preventive treatment of migraine in adults. VYEPTI is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of its ingredients. Reactions have included anaphylaxis and angioedema. Please see Important Safety Information below.
Lundbeck VYEPTI Migraine Data at AHS
Presentation | Summary | Presentation Number |
Real-world effectiveness of eptinezumab treatment on migraine-related cognitive symptoms in participants in whom ≥1 prior CGRP-targeted therapy had failed: 12-month results of the INFUSE study
|
| T 15 |
Reductions in Headache hours with severe pain intensity with eptinezumab treatment: Post hoc analysis of the DELIVER trial
|
| T 29 |
Dose escalation to eptinezumab 300 mg: A subgroup analysis of the 60-week, open-label SUNSET trial in Japanese participants with chronic migraine who experienced suboptimal response |
| T 17 |
Consistent efficacy of eptinezumab across countries in adults with CM and MOH who also received patient education: Results from the RESOLUTION trial |
| T 26 |
Lundbeck will also sponsor a symposium, titled “Advancing Migraine Care: Exploring real-world patient-reported outcomes after anti-CGRP treatment failure,” featuring Drs. Christopher H. Gottschalk, Director, Headache Medicine, Yale School of Medicine, and Amaal J. Starling, INFUSE study author and neurologist, Mayo Clinic, on Friday, June 5 at 12:30 pm ET. The symposium will highlight the real-world, survey-based study assessing established and novel patient-reported outcomes including Patient Global Impression of Change (PGIC), ≥50% and ≥75% reductions in Monthly Headache Days (MHD), good days and brain fog, among patients who initiated VYEPTI after previously failing at least one CGRP-targeted treatment.
Additionally, six-month results from the INFUSE study were recently published in Cephalalgia Reports, evaluating real-world outcomes on patient-reported migraine symptoms, including daily functioning and brain fog in adults treated with VYEPTI for whom at least one prior anti-CGRP preventive therapy had failed.
Lundbeck Migraine Portfolio Data at AHS
Lundbeck will also present new data on investigational drug bocunebart. Bocunebart is an investigational drug, not approved for use by the U.S. Food and Drug Administration (FDA) or any other regulatory agency, and the efficacy and safety of bocunebart have not been established.
Presentation | Summary | Presentation Number |
Safety and Tolerability of Anti-PACAP Monoclonal Antibody Lu AG09222 when Co-administered with a Gepant in Participants with Migraine
|
| T 10 |
Targeting PACAP in migraine prevention: Outcomes from the PROCEED phase 2b trial of bocunebart (Lu AG09222) |
| T 110 |
About VYEPTI
VYEPTI® (eptinezumab-jjmr) is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor. VYEPTI was deliberately developed for administration by IV infusion to deliver 100 percent of the medication into the bloodstream at the end of the infusion.
The efficacy and safety of VYEPTI were demonstrated in two phase 3 clinical trials; episodic migraine in PROMISE-1 and chronic migraine in PROMISE-2. VYEPTI met its primary endpoint of decrease in mean monthly migraine days (MMD) over months 1-3 in both episodic and chronic migraine. The safety of VYEPTI was evaluated in 2,076 patients with migraine who received at least one dose of VYEPTI. The most common adverse reactions (≥2 percent and at least 2 percent 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 percent of patients treated with VYEPTI discontinued treatment due to adverse reactions.
VYEPTI offers patients with migraine a preventive treatment administered as one 30-minute IV infusion 4 times a year (every three months). The recommended dosage is 100 mg, and some patients may benefit from a dosage of 300 mg. Dosing should be based on the guidance in the Prescribing Information and Patient Information.
INDICATION
VYEPTI (eptinezumab-jjmr) is indicated for the preventive treatment of migraine in adults.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
VYEPTI is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of the excipients. Reactions have included anaphylaxis and angioedema.
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions: Hypersensitivity reactions, including angioedema, urticaria, facial flushing, dyspnea, and rash, have occurred with VYEPTI in clinical trials and in the postmarketing setting. Most hypersensitivity reactions occurred during infusion and were not serious, but often led to discontinuation or required treatment. Serious hypersensitivity reactions may occur. Cases of anaphylaxis have been reported in the postmarketing setting. If a hypersensitivity reaction occurs, consider discontinuing VYEPTI and institute appropriate therapy.
Hypertension: Development of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists, including VYEPTI, in the postmarketing setting. Some of the patients who developed new-onset hypertension had risk factors for hypertension. There were cases requiring initiation of pharmacological treatment for hypertension, and in some cases hospitalization. Hypertension may occur at any time during treatment, but was most frequently reported within 7 days of therapy initiation. The CGRP antagonist was discontinued in many of the reported cases.
Monitor patients treated with VYEPTI for new-onset hypertension or worsening of pre-existing hypertension, and consider whether discontinuation of VYEPTI is warranted if evaluation fails to establish an alternative etiology or blood pressure is inadequately controlled.
Raynaud’s Phenomenon: Development of Raynaud’s phenomenon and recurrence or worsening of pre-existing Raynaud’s phenomenon have been reported in the postmarketing setting following the use of CGRP antagonists. In reported cases with monoclonal antibody CGRP antagonists, symptom onset occurred a median of 71 days following dosing. Many of the cases reported serious outcomes, including hospitalizations and disability, generally related to debilitating pain. In most reported cases, discontinuation of the CGRP antagonist resulted in resolution of symptoms.
VYEPTI should be discontinued if signs or symptoms of Raynaud’s phenomenon develop, and patients should be evaluated by a healthcare provider if symptoms do not resolve. Patients with a history of Raynaud’s phenomenon should be monitored for, and informed about the possibility of, worsening or recurrence of signs and symptoms.
ADVERSE REACTIONS
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.
VYEPTI was approved by the U.S. Food and Drug Administration (FDA) for the preventive treatment of migraine in adults in February 2020. For more information, please see Full Prescribing Information and Patient Information or visit www.VYEPTIHCP.com.
About Migraine Disease
Migraine is a complex and disabling neurological disease that limits functionality and quality of life.7,8 It is characterized by moderate to severe head pain typically accompanied by an array of symptoms, including nausea, vomiting and sensitivity to light or sound.7 Over time, migraine disease may worsen, with attacks increasing in frequency, severity and duration.9 It is estimated to affect more than 40 million adults in the U.S. and impacts three times as many women than men.10 Headache disorders are a leading cause of years lived with disability (YLD) among all diseases and is a top 5 cause for 10–24-year-olds, according to the 2019 Global Burden of Disease study.11 The impact of migraine permeates into career, home life and relationships.12
About the INFUSE study
The INFUSE study is a 12-month, prospective, observational study in the US, assessing real-world effectiveness of intravenous (IV) eptinezumab-jjmr (100 mg or 300 mg) in adults with migraine who previously failed at least one preventive anti-CGRP. Data were collected via digital platform at baseline, Day 7, and Months 3, 6, 9 and 12 through participant-reported surveys. The primary outcome was percent of patients with “much” or “very much” improved on the 7-point PGIC scale (“very much improved,” “much improved,” “minimally improved,” “no change,” “minimally worse,” “much worse,” or “very much worse”). Secondary outcomes included monthly headache days and ≥50% reduction in monthly headache days (MIDAS-derived) and number of patient-defined “good days”. INFUSE did not collect safety data, but postmarketing adverse events are monitored and reported through established safety reporting channels.
About the DELIVER trial
DELIVER (NCT04418765) is a Phase 3b, multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of eptinezumab-jjmr in patients with chronic or episodic migraine. Chronic migraine was defined as migraine occurring on ≥8 days per month and headache occurring on >14 days, and episodic migraine as migraine occurring on ≥4 days and headache occurring on ≤14 days. All patients had to have experienced failures of two to four prior preventive treatment classes (including: propranolol, metoprolol, topiramate, amitriptyline, flunarizine, valproate, divalproex, candesartan) or botulinum toxin A/B (if documented that botulinum toxin was used for chronic migraine), and at least one failure being due to inadequate efficacy. Patients who experienced failure on a previous treatment targeting the CGRP pathway were excluded from participation. Documented evidence of prior migraine treatment failures was supported by medical records or by physicians’ confirmation specific to each treatment in the past 10 years.
About the SUNSET trial
The SUNSET trial (NCT05064371) was an extension of the phase 3, multiregional, randomized, double-blind, placebo-controlled SUNRISE trial (NCT04921384) conducted in adults (18–75 years) diagnosed with chronic migraine. 159 Japanese participants who completed SUNRISE were enrolled and treated in SUNSET after completing 12-week, randomized, double-blind treatment with IV eptinezumab-jjmr 100 mg, 300 mg, or placebo. SUNSET comprised a 60-week open-label treatment period (during which participants received IV eptinezumab-jjmr every 12 weeks [5 doses total] and completed a daily electronic diary) and an 8-week safety follow-up period. All participants received eptinezumab-jjmr 100 mg at baseline in SUNSET, participants who did not achieve ≥50% reduction from SUNRISE baseline in monthly migraine days (MMDs; SUNSET Weeks 1–12) had their dose increased to 300 mg at SUNSET Week 12 and onward.
The primary endpoints investigated long-term safety and tolerability, including treatment emergent adverse events (TEAEs). Secondary endpoints included change from baseline in the number of MMDs, ≥50% and ≥75% migraine responder rates (MRRs), and Patient Global Impression of Change (PGIC) score. Exploratory endpoints included change from baseline in the Migraine-specific Work Productivity and Activity Impairment (WPAI:M) questionnaire domain scores.
About the RESOLUTION trial
The RESOLUTION trial was a phase IV, multi-national, randomized, double-blind, placebo-controlled trial. The trial enrolled 608 participants with dual diagnoses of chronic migraine and MOH, and participants were randomly allocated to one of two treatment groups, brief educational intervention (BEI) and eptinezumab-jjmr (100 mg; n = 305) or BEI and placebo (n = 303), in a 1:1 ratio. BEI involves a short screening followed by individual feedback on how and why acute migraine medication use should be reduced, and this approach to patient education has been shown to result in long-term medication reductions for patients with MOH.
RESOLUTION is the first randomized controlled trial to assess the efficacy of an anti-CGRP treatment in combination with structured patient education in chronic migraine and MOH. The primary endpoint was the change from baseline in monthly migraine days over weeks 1-4. Key secondary endpoints included change from baseline in average daily pain assessment score (as accessed by 3-point pain intensity scale, mild, medium, severe), and change from baseline in acute medication use over 1-12 weeks. Other secondary and exploratory endpoints assessed monthly migraine days over weeks 1-12, MOH remission, transition from chronic to episodic migraine, reductions in headache-related burden, migraine-related disability, work productivity loss, activity impairment, and the safety and tolerability of eptinezumab-jjmr in this patient population. The participants in the RESOLUTION trial were mainly from European countries.
About bocunebart
Bocunebart is an investigational monoclonal antibody (mAb) with a novel mechanism of action. It is engineered to bind to and inhibit the signaling of pituitary adenylate cyclase-activating polypeptide (PACAP), a neuropeptide implicated in migraine pathophysiology. This mechanism operates through a pathway distinct from that targeted by anti-calcitonin gene-related peptide (anti-CGRP) therapies. Bocunebart represents a potential new treatment class and could provide an alternative option for migraine prevention, offering hope to individuals severely affected by the condition.
Bocunebart is an investigational drug, not approved by the US Food and Drug Administration (FDA) or any other regulatory agency, and the efficacy and safety of bocunebart have not been established.
About the PROCEED trial
The PROCEED trial assessed the efficacy, safety, and tolerability of bocunebart versus placebo when administered once monthly for three months. The PROCEED trial aimed to establish the optimal dose and route of administration, subcutaneous and IV, of bocunebart. In the IV part of PROCEED a total of 431 patients from 14 countries (Bulgaria, Czechia, Denmark, France, Georgia, Germany, Hungary, Lithuania, Japan, Poland, Romania, Slovakia, Spain, and the United States) were randomized. The primary efficacy endpoint was defined as the difference between bocunebart and placebo in the mean change from baseline in the number of monthly migraine days over weeks 1 to 12. The target population for this trial was defined as patients diagnosed with migraine as outlined in the International Classification of Headache Disorders Third Edition (ICHD-3) and with treatment failure of 1-4 different preventive migraine medications in the past 10 years.
About Lundbeck
Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases.
Brain disorders affect a large part of the world’s population, and the effects are felt throughout society. With the rapidly improving understanding of the biology of the brain, we hold ourselves accountable for advancing brain health by curiously exploring new opportunities for treatments.
As a focused innovator, we strive for our research and development programs to tackle some of the most complex neurological challenges. We develop transformative medicines targeting people for whom there are few or no treatments available, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.
We are committed to fighting stigma and we act to improve health equity. We strive to create long-term value for our shareholders by making positive contributions to patients, their families and society as a whole. Lundbeck has more than 5,000 employees in more than 20 countries and our products are available in more than 80 countries.
Lundbeck US comprises the wholly owned US subsidiaries of H. Lundbeck A/S (HLUNa / HLUNb, HLUNA DC / HLUNB DC) (“Lundbeck”), including Lundbeck LLC and Lundbeck Pharmaceuticals LLC. For additional information, please visit Lundbeck.com/us and connect with us on LinkedIn, Instagram, and X at @LundbeckUS.
References
- Starling, A., Lipton, R., Soni-Brahmbhatt., et al. Real-World Impact of Eptinezumab Treatment on Migraine-Related Cognitive Symptoms in Participants in Whom ≥1 Prior CGRP-Targeted Therapy had Failed: 12-Month Results of a Prospective Study. Presented at American Headache Society 68th Annual Scientific Meeting. June 2026.
- Ailani, J., Phul, R., Florea, I., et al. Targeting PACAP in migraine prevention: Outcomes from the PROCEED phase 2b trial of bocunebart (Lu AG09222). Presented at American Headache Society 68th Annual Scientific Meeting. June 2026.
- Tassorelli, C., Awad, S., Grossman, S., et al. Headache hours with severe pain intensity during long-term treatment with eptinezumab: Post hoc analysis of the DELIVER trial. Presented at American Headache Society 68th Annual Scientific Meeting. June 2026.
- Mcallister, P., Asher, D., Awad, S., et al. Dose escalation to eptinezumab 300 mg: A subgroup analysis of the 60-week, open-label SUNSET trial in Japanese participants with chronic migraine who experienced suboptimal response. Presented at American Headache Society 68th Annual Scientific Meeting. June 2026.
- Lipton, R., Terwindt, G., Jensen, R., et al. Consistent efficacy of eptinezumab across countries in adults with CM and MOH who also received patient education: Results from the RESOLUTION trial. Presented at American Headache Society 68th Annual Scientific Meeting. June 2026.
- Starling, A., Ailani, J., Florea, I., et al. Safety and Tolerability of Anti-PACAP Monoclonal Antibody Lu AG09222 when Co-administered with a Gepant in Participants with Migraine. Presented at American Headache Society 68th Annual Scientific Meeting. June 2026.
- What is migraine? nids.nih.gov
- Law H. Z., Chung M. H., Nissan G., Janis J. E., Amirlak B. Hospital burden of migraine in United States adults: A 15-year national inpatient sample analysis. 2020.
- Lipton R. B., Buse D. C., Nahas S. J., et al. Risk factors for migraine disease progression: a narrative review for a patient-centered approach. J Neurol. 2023;270(12):5692-5710. doi:10.1007/s00415-023-11880-2
- Cohen, F., Brooks, C. V., Sun, D., Buse, D. C., Reed, M. L., Fanning, K. M., & Lipton, R. B. (2024). Prevalence and burden of migraine in the United States: A systematic review. Headache, 64(5), 516–532. https://doi.org/10.1111/head.14709
- Global burden of 369 diseases and injuries in 204 countries and territories, 1990–2019: a systematic analysis for the Global Burden of Disease Study 2019.
- Buse D. C., Scher A. I., Dodick D. W., et al. Impact of Migraine on the family: Perspectives of people with migraine and their spouse/domestic partner in the CaMEO study. Mayo Clinic. 2016, 91(5):596-611. doi: 10.1016/j.mayocp.2016.02.013.
Contacts
Brittany Korb
Director, Product and Portfolio Communications
brkr@lundbeck.com
