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DEERFIELD, Ill., June 19, 2025 – Lundbeck US, the US subsidiaries of H. Lundbeck A/S, today announced it will present one oral and eight poster presentations at the 67th Annual Scientific Meeting of the American Headache Society (AHS) in Minneapolis from June 19-22, 2025. The data presentations reinforce the need to look beyond monthly migraine days (MMDs) and the importance of a holistic approach to migraine care as suggested by data from eptinezumab-jjmr post-hoc analyses.
VYEPTI® (eptinezumab-jjmr) 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 disease affects over 40 million people in the U.S.,1 profoundly impacting every aspect of life for many,” said Damian Fiore, Vice President, Lundbeck US Medical Affairs Neurology. “Lundbeck is energized to be at AHS, driving conversations on how we can better understand the holistic burden of migraine and redefine how we approach care. Our focus goes beyond just alleviating individual symptoms—we are committed to improving the overall quality of life for people living with migraine disease.”
Analyses presented at AHS from several studies including clinical trials and real-world research continue to focus on novel ways to assess VYEPTI and study results and advance preventive migraine care:
Further highlighting our commitment to pushing the boundaries on migraine care with preventive treatments, Lundbeck also will host a symposium titled, “Why the interictal period matters: Striving for migraine freedom” with Dr. Amaal Starling and Dr. Stewart Tepper on Thursday, June 19 from 12:30 p.m. to 1:15 p.m. CT.
“For optimal migraine management, it’s important to prioritize continuous improvement and a patient-centered approach,” said Dr. Amaal Starling, Neurologist, Mayo Clinic. “These studies highlight the real-world impact of preventive migraine treatments that can provide sustained control, which may allow individuals to focus on their personal goals and live their lives to the fullest.”
Additional migraine data being presented at AHS include:
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.1 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.1,11 Over time, migraine disease may worsen, with attacks increasing in frequency, severity and duration.12,13 It is estimated to affect more than 40 million people in the U.S. and impacts three times as many women than men.1 It is the second leading cause of years lived with disability (YLD) among all diseases and is the top YLD cause among people aged 15 to 49 years, according to the Global Burden of Disease study. The impact of migraine permeates into career, home life and relationships.14
About INFUSE study
INFUSE is an ongoing, non-interventional, prospective study in individuals with migraine, initiating preventive treatment with eptinezumab-jjmr. Eligible participants were recruited by two infusion center networks and are being followed for 12 months after initiating eptinezumab-jjmr treatment. INFUSE includes adults ≥18 years of age with a diagnosis of migraine who tried ≥1 preventive a-CGRP treatment (erenumab, fremanezumab, galcanezumab, atogepant, or rimegepant [prescribed every other day]).
About DELIVER study
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 calcitonin gene-related peptide (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.
In the study, 892 patients were randomized to receive eptinezumab-jjmr 100 mg or 300 mg or placebo by IV infusion. Patients included in the study most frequently experienced treatment failures of topiramate and amitriptyline, with 550(61.8%), 277(31.1%), and 60(6.7%) patients experiencing 2, 3, and 4 prior preventive treatment failures respectively. The primary endpoint was change from baseline in the number of monthly migraine days over Weeks 1-12. Key secondary endpoints included response rates as patients with 50% or greater reduction from baseline in MMDs (Weeks 1-12), response rates of patients with 75% or greater reduction from baseline in MMDs (Weeks 1-12) and change from baseline in the number of MMDs (Weeks 13-24). Other secondary endpoints assessed the effect of eptinezumab-jjmr vs placebo on: 6-item Headache Impact test score (HIT-6), Migraine-specific quality of life (MSQ v2.1), HRQoL (EQ-5D-5L) visual analogue scale (VAS) score, healthcare resources utilization (HCRU), and Work Productivity and Activity Impairment Questionnaire (WPAI).
The safety and tolerability of eptinezumab-jjmr in the DELIVER study were similar to placebo and consistent with findings from previous eptinezumab-jjmr clinical trials. In DELIVER and earlier eptinezumab-jjmr studies, upper respiratory tract infection, nasopharyngitis, dizziness, and fatigue were the most commonly reported treatment-emergent adverse events (TEAEs).
About PREVAIL study
PREVAIL was a phase 3, open-label multi-site U.S.-based study that evaluated eptinezumab-jjmr 300 mg intravenous administration in 128 adults with chronic migraine (CM). PREVAIL included two treatment phases: the primary treatment phase included four infusions of eptinezumab-jjmr 12 weeks apart (Day 0, and Weeks 12, 24, and 36); the secondary treatment phase included up to four additional eptinezumab-jjmr infusions 12 weeks apart (Weeks 48, 60, 72, and 84). Further, patients were followed for 20 additional weeks after the final infusion until Week 104. The PREVAIL study evaluated the long-term safety of repeat doses of eptinezumab-jjmr 300 mg in patients with CM, as well as the pharmacokinetics, immunogenicity, and patient-reported outcomes (PROs). Patient-reported outcome measures included the Migraine Disability Assessment (MIDAS) questionnaire, patient-identified most bothersome symptom (PI-MBS) associated with migraine, Patient Global Impression of Change (PGIC), and 6-item Headache Impact Test (HIT-6).
About a-PACAP
a-PACAP monoclonal antibody is an investigational compound currently under development (phase 2) for the treatment of migraine. The compound is not commercially available globally.
Contact
Brittany Korb
Director, Product Communications and Patient Advocacy
brkr@lundbeck.com
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 approximately 5,700 employees in more than 50 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 and X at @LundbeckUS.
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