Lundbeck to Present Broad Range of Data on Migraine and Brain Health at 75th Annual Meeting of the American Academy of Neurology

• Breadth of data showcases Lundbeck’s commitment to advancing neuroscience
• New clinical and real-world evidence supporting VYEPTI as a preventive migraine treatment in adults; medical symposium to feature interactive, case-base discussion on incorporating preventive care research into practice
• Harris Poll Migraine Report Card survey reveals stigma and gaps in migraine care

DEERFIELD, Ill.--(BUSINESS WIRE)--Lundbeck today announced new neuroscience data will be presented at the 75^th Annual Meeting of the American Academy of Neurology taking place in Boston and virtually from April 22-27, 2023. A total of 12 abstracts, including post-hoc and real-world analyses of VYEPTI^® (eptinezumab-jjmr), an anti-CGRP monoclonal antibody for the preventive treatment of migraine, as well as the impact of migraine on sufferers will be featured in two oral and ten poster presentations. The company is also sponsoring a medical symposium, “Migraine: Your Patient, Your Partner. Proactive care for high-frequency, worsening disease,” focusing on studies and techniques for individualizing preventive care to improve collaboration and outcomes.

“Migraine is a common, debilitating neurologic disease that impacts patients in the prime of their productivity and limits functionality and quality of life,” said Marija Geertsen, M.D., MBA, Vice President, U.S. Medical Affairs, Lundbeck. “At Lundbeck, researching and developing transformative medicines for brain health is at the core of what we do. The breadth of our data underscores our commitment to showcasing the efficacy and real-world experience with VYEPTI, and uncovering the stigma, unique perspectives, and concerns that impact the quality of life for those living with migraine disease.”

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 full Important Safety Information below.

Key abstracts include:

• Results from Harris Poll Migraine Report Card Survey find adults with high-frequency migraine and acute medication overuse more likely to experience stigma
  (Abstract #2406; poster)¹
  The Harris Poll Migraine Report Card survey evaluated self-reported stigma in 550 U.S. adults with high-frequency headache/migraine (HFM) and acute medication overuse (AMO), defined as at least eight days/month with headache/migraine with at least
  10 days/month of acute headache medication use.
  
  The survey found that adults with current HFM and AMO were more likely than those with previous HFM and AMO to always/often experience six of the eight measures on the Stigma Scale for Chronic Illnesses (SSCI-8; P<0.1), while women with current HFM and AMO were more likely to always/often experience seven of the eight SSCI-8 measures (P<0.1). Certain stigma experiences were significantly more common in men, younger adults, and Black adults with current HFM and AMO.

• No wearing off effect observed with VYEPTI in the preventive treatment of migraine (Abstract #2246; poster)²
  A post-hoc analysis of the pivotal Phase 3 PROMISE-2 (NCT02974153) study evaluating the consistency of weekly migraine frequency during the first dosing interval (12 weeks) found that there was no evidence of “wearing off” of VYEPTI’s preventive benefit prior to the second infusion.

• Real-world data reflects magnitude of improvement with VYEPTI treatment in controlled clinical trials (Abstract #1343; poster)³
  A retrospective analysis of 31 patients with migraine treated with VYEPTI between April and October 2020 found that early clinical experience and clinical improvement are consistent with results reported in controlled clinical trials, with reductions in headache and migraine frequency and associated disability evident during the first six months of treatment.
  
  Patients who received six months of preventive treatment with VYEPTI experience reduction in mean monthly headache days relative to baseline (23.5 at baseline, 16.3 at Month 6), mean monthly migraine days (17.9 at baseline, 9.1 at Month 6), and patient-reported disability (50.0% [11/22] severe at baseline per MIDAS and/or HIT-6, 36.8% [7/19] severe at Month 6). VYEPTI was also associated with reduced acute headache medication use (16.7 mean acute medication days per month in the last 3 months prior to treatment and 8.3 at Month 6). Clinicians reported that treatment was well-tolerated (96.8% (30/31)) and improved disability/function (77.4% (24/31)) after six months of use.

• Survey findings suggest that 75% of patients living with migraine are not averse to IV infusion as a route of administration (Abstract #1368; poster)⁴
  A non-interventional, cross-sectional study of 604 patients with self-reported migraine diagnoses who experienced at least five monthly migraine days and had tried at least two prescription migraine treatments was conducted to assess the relative importance of five attributes in the choice of preventive migraine treatment.
  
  The study, administered via a 25-minute discrete choice online survey, identified four groups with differing preferences: those preferring auto-injection (n=128, 21%); those averse to cranial injections (n=189, 31%); those preferring faster speed of onset (n=158, 26%); and those preferring longer durability and clinicians to administer treatment (n=129, 21%). Except for those preferring auto-injection, all patients – three-quarters of study participants – indicated that they were not averse to IV infusion as a route of administration.

Additional data to be presented by Lundbeck at AAN 2023 is listed below.

• Abstract #1658: Preventive Treatment with Eptinezumab in Patients with a Dual Diagnosis of Chronic Migraine and Medication-Overuse Headache: Subgroup Analysis of PROMISE-2 (oral)⁵
• Abstract #3196: Responder Rates With Eptinezumab Over 24 Weeks in Patients With Prior Migraine Preventive Treatment Failures (oral)⁶
• Abstract #3179: Patient-Identified Most Bothersome Symptom as a Driver of Health-Related Quality of Life Experienced by Patients with Migraine (poster)⁷
• Abstract #3020: Impact of Eptinezumab on Work Productivity Beyond Reductions in Monthly Migraine Days: Post Hoc Analysis of the DELIVER Trial (poster)⁸
• Abstract #1523: Effect of Eptinezumab on Utility Scores in Patients with Migraine: Results from the DELIVER Study (poster)⁹
• Abstract #3244: Persistence to OnabotulinumtoxinA or Calcitonin Gene-Related Peptide Monoclonal Antibody Therapy Among Patients With Migraine: A Retrospective Cohort Study (poster)¹⁰
• Abstract #2498: Health Concerns and Treatment Perspectives Among US Adults with Current Versus Previous High-Frequency Headache/Migraine and Acute Medication Overuse: The Harris Poll Migraine Report Card Survey (poster)¹¹
• Abstract #1161: Development and Validation of a Novel Model for Characterizing Migraine Outcomes Within Electronic Health Records Utilizing Artificial Intelligence (poster)¹²

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.

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 the PROMISE 1 and PROMISE 2 Studies
PROMISE 1 and PROMISE 2 were phase 3, multicenter, randomized, placebo-controlled studies, both with 6-month double-blind periods, which evaluated the efficacy and safety of VYEPTI as a preventive treatment of episodic migraine and chronic migraine in adults, respectively. In PROMISE 1, episodic migraine was defined as 4-14 headache days per month, of which at least 4 were migraine days. Chronic migraine in PROMISE 2 was defined as 15-26 headache days per month, of which at least 8 were migraine days.

In PROMISE 1, a total of 665 patients were randomized to receive placebo (n=222), 100 mg VYEPTI (n=221), or 300 mg VYEPTI (n=222) every 3 months for 12 months. PROMISE 2 included a total of 1,072 patients who were randomized to receive placebo (n=366), 100 mg VYEPTI (n=356), or 300 mg VYEPTI (n=350) every 3 months for 6 months. The primary endpoint in each study was the change from baseline in mean monthly migraine days (MMD) over Months 1-3. The most common adverse reactions (≥2% and at least 2% or greater than placebo) were nasopharyngitis and hypersensitivity.

Patients were allowed to use concurrent acute migraine or headache medications, including migraine-specific medications (i.e., triptans, ergotamine derivatives), during the trials. Both studies excluded patients with a history of cardiovascular disease (hypertension, ischemic heart disease), neurological disease, and cerebrovascular disease. In PROMISE 2, the study population included patients with a dual diagnosis of chronic migraine and medication-overuse headache attributable to overuse of acute medications: triptans, ergotamine, or combination analgesics greater than 10 days per month.

About H. Lundbeck A/S
Lundbeck is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best.

We are committed to fighting stigma and discrimination against people living with brain diseases and advocating for broader social acceptance of people with brain health conditions. Our research programs tackle some of the most complex challenges in neuroscience, and our pipeline is focused on bringing forward transformative treatments for brain diseases for which there are few, if any therapeutic options.

For additional information, we encourage you to visit our corporate site www.lundbeck.com and connect with us on Twitter at @Lundbeck and via LinkedIn.

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¹ Buse DC, et al. Migraine-Related Stigma in Adults With Current Versus Previous High-Frequency Migraine and Acute Medication Overuse: Results of the Harris Poll Migraine Report Card Survey. Available at: https://index.mirasmart.com/aan2023/PDFfiles/AAN2023-002406.html. Accessed March 20, 2023
² Cady R, et al. Lack of “wearing off” effect with eptinezumab in the preventive treatment of migraine. Available at: https://index.mirasmart.com/aan2023/PDFfiles/AAN2023-002246.html. Accessed March 20, 2023.
³ Starling AJ, et al. Early Clinical Experience With Eptinezumab From a Retrospective, Observational Study of Real-World Patient Response. Available at: https://index.mirasmart.com/aan2023/PDFfiles/AAN2023-001343.html. Accessed March 20, 2023.
⁴ Schwedt TJ, et al. Patient Preferences for Attributes of Advanced Migraine Prevention Medications: Findings from a Discrete Choice Experiment. Available at: https://index.mirasmart.com/aan2023/PDFfiles/AAN2023-001368.html. Accessed March 20, 2023.
⁵ Marmura MJ, et al. Preventive Treatment With Eptinezumab in Patients With a Dual Diagnosis of Chronic Migraine and Medication-Overuse Headache: Subgroup Analysis of PROMISE-2. Available at: https://index.mirasmart.com/aan2023/PDFfiles/AAN2023-001658.html. Accessed March 20, 2023.
⁶ Ashina M, et al. Responder Rates With Eptinezumab Over 24 Weeks in Patients With Prior Migraine Preventive Treatment Failures. Available at: https://index.mirasmart.com/aan2023/PDFfiles/AAN2023-003196.html. Accessed March 20, 2023.
⁷ Jonsson L, et al. Patient-identified most bothersome symptom as a driver of health-related quality of life experienced by patients with migraine. Available at: https://index.mirasmart.com/aan2023/PDFfiles/AAN2023-003179.html. Accessed March 20, 2023.
⁸ Barbanti P, et al. Impact of eptinezumab on work productivity beyond reductions in monthly migraine days: Post hoc analysis of the DELIVER trial. Available at: https://index.mirasmart.com/aan2023/PDFfiles/AAN2023-003020.html. Accessed March 20, 2023.
⁹ Jonsson L, et al. Effect of Eptinezumab on Utility Scores in Patients with Migraine: Results from the DELIVER Study. Available at: https://index.mirasmart.com/aan2023/PDFfiles/AAN2023-001523.html. Accessed March 20, 2023.
¹⁰ Talon B, et al. Persistence to OnabotulinumtoxinA or Calcitonin Gene-Related Peptide Monoclonal Antibody Therapy Among Patients With Migraine: A Retrospective Cohort Study. Available at: https://index.mirasmart.com/aan2023/PDFfiles/AAN2023-003244.html. Accessed March 20, 2023.
¹¹ Starling AJ, et al. Health concerns and treatment perspectives among US adults with current versus previous high-frequency headache/migraine and acute medication overuse: The Harris Poll Migraine Report Card Survey. Available at: https://index.mirasmart.com/aan2023/PDFfiles/AAN2023-002498.html. Accessed March 20, 2023.
¹² Kymes S, et al. Development and validation of a novel model for characterizing migraine outcomes within electronic health records utilizing artificial intelligence. Available at: https://index.mirasmart.com/aan2023/PDFfiles/AAN2023-001611.html. Accessed March 20, 2023.

Brittany Korb
Associate Director, Product and Business Unit Communications
brkr@lundbeck.com