Lundbeck today presented new real-world 6-month results from the INFUSE study at the American Academy of Neurology (AAN) 2026 Annual Meeting, underscoring the importance of evaluating the broad burden of migraine beyond headache and migraine frequency. Despite being among the most frequently reported symptoms by people living with migraine, cognition and brain fog have rarely been systematically studied. These patient-reported outcomes data highlight the opportunity to focus on elements of migraine burden that are meaningful to individuals living with migraine and report improvement of migraine-related cognitive symptoms after VYEPTI® (eptinezumab-jjmr) treatment.1
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.
“Migraine is a highly individualized neurological disease characterized by fluctuating symptoms, disability, and quality-of-life impairment. My patients often describe ‘brain fog’ associated with migraine as profoundly disruptive, hindering their ability to perform at work, engage with family, or simply enjoy daily life,” said INFUSE study author Dr. Amaal Starling, Neurologist, Mayo Clinic. “The INFUSE study findings are meaningful as patients report improvements in cognitive symptoms associated with migraine after starting VYEPTI. These data further support more comprehensive goals with patients who have high disease burden despite prior anti-CGRP preventive treatment to better address their needs and improve outcomes.”
Data from the 6-month interim analysis of the INFUSE study underscored the importance of real-world evidence to inform clinical practice with the aim to address the holistic burden of migraine with preventive treatments. This specific analysis focused on cognitive improvements. The study demonstrated that migraine-related cognitive symptoms are highly prevalent and bothersome among patients at baseline. Specific symptoms that were considered moderately to extremely bothersome, like difficulty making decisions, difficulty with reading comprehension, difficulty with complex tasks, and brain fog (difficulty concentrating/focusing, trouble finding right words/speaking, mental cloudiness) were reported by 64.7%, 60.0%, 62.6%, and 82.1% of participants, respectively. This population, characterized by a high disease impact, reported improvements following treatment with VYEPTI. Across individual cognitive symptoms (brain fog, difficulty making decisions, difficulty with reading comprehension and difficulty with complex tasks), more than 50% of participants reported improvements at 6 months (after 2 doses of VYEPTI) compared to baseline, with marked improvements observed as early as Day 7 post-treatment.1
“These real-world, patient-reported INFUSE data give greater insight into the management of the holistic burden of migraine – including highly prevalent cognitive symptoms – to better support optimal treatment decisions,” said Damian Fiore, Vice President, Lundbeck US Medical Affairs Neurology. “We’re excited to share new data that may help redefine expectations for preventive migraine treatment and reinforce our commitment to raising the standard of migraine care.”
Additional VYEPTI data being presented at AAN are:
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.2,3 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.2 Over time, migraine disease may worsen, with attacks increasing in frequency, severity and duration.4 It is estimated to affect more than 40 million people in the U.S. and impacts three times as many women than men.5 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.6 The impact of migraine permeates into career, home life and relationships.7
About 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 digitally 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 these data are reported via the established safety reporting channels.
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
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___________________________ 1 Starling, A., Estemalik, E., Lipton, R., et al. Real-world Improvements in Cognitive Symptoms After Eptinezumab Treatment in Patients in Whom ≥1 Prior Anti-CGRP Preventive Treatment had Failed: 6-month Results for the Ongoing INFUSE Study. Presented at American Academy of Neurology 2026 Annual Meeting. April 2026. 2 What is migraine? nids.nih.gov 3 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. 4 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 5 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 6 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. 7 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. |
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