Lundbeck to Present New Clinical and Real-World VYEPTI® (eptinezumab-jjmr) Data at the 65th Annual Scientific Meeting of the American Headache Society, Reinforcing Its Use in Migraine Prevention

• First-time presentation of a real-world evidence study that revealed high overall satisfaction with the effectiveness of VYEPTI treatment for chronic migraine among most patients and their treating neurologists, as well as positive infusion experience
• Harris Poll Migraine Report Card Survey uncovers racial and ethnic treatment disparities amongst people living with migraine in the U.S.
• Growing clinical and real-world evidence supporting VYEPTI highlights Lundbeck’s commitment in meeting the diverse needs of people with migraine

DEERFIELD, Ill.--(BUSINESS WIRE)--Lundbeck today announced new VYEPTI^® (eptinezumab-jjmr) data will be presented at the 65^th Annual Scientific Meeting of the American Headache Society (AHS) taking place in Austin, Texas, and virtually from June 15—18, 2023. A total of nine data presentations will be featured, including real-world experience with VYEPTI, an anti-CGRP monoclonal antibody for the preventive treatment of migraine in adults, and one oral presentation highlighting disparities in migraine care and treatment from the Harris Poll Migraine Report Card Survey. In addition, Lundbeck will be sponsoring a symposium on Friday, June 16^th titled “Research to Practice. Clinical implications of real-world use of an anti-CGRP mAb in high frequency migraine” led by Drs. Richard Lipton, Wade Cooper, and Amaal Starling.

“It’s critical for us at Lundbeck to continue meaningful conversations around health disparities and how to address the stigma that people living with migraine face every day,” said Marija Geertsen, M.D., MBA, Vice President, U.S. Medical Affairs, Lundbeck. “With our focus on brain health and advancing innovative treatments for migraine, we’re excited to share new data that showcases real-world experiences with VYEPTI in patients with chronic migraine in the clinical setting.”

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.

Key abstracts include:

• Real-world evidence revealed high overall satisfaction with the effectiveness of VYEPTI treatment for chronic migraine, as well as positive infusion experience^1,2
  Real-world Evidence and Insights into Experiences With eptinezumab-jjmr (REVIEW), an observational study, assessed real-world experiences with VYEPTI treatment among patients and physicians, including satisfaction with symptomology, quality of life, and infusion experience.
  
  The REVIEW study provides insights into the experiences of 94 patients who had received at least two doses eptinezumab-jjmr in the clinical setting. Patients surveyed in this study (Poster #165) were not excluded on basis of prior treatment with an anti-CGRP, and 89% reported at least 1 prior anti-CGRP mAb before VYEPTI. The study found the number of “good” days more than doubled following VYEPTI treatment (8 “good” days per month before VYEPTI and 18 “good” days per month after one dose). The proportion of patients reporting at least 10 days per month of over the counter or prescription medication for acute treatment were reduced by approximately two-thirds after VYEPTI. Furthermore, the majority of patients expressed satisfaction with the efficacy of VYEPTI to make migraine symptoms less severe (79%), to reduce the frequency (76%) and duration (66%) of migraine symptoms. Patients reported higher or much higher satisfaction with various elements of daily living and well-being after starting treatment with VYEPTI, including the ability to plan life, participation in social/family life, productivity at daily responsibilities, and confidence in overall well-being.
  
  Regarding the infusion experience (Poster #140), while 62% of patients reported feeling some level of concern before receiving their first dose of VYEPTI, only 14% had any level of concern following treatment. In addition, almost all patients (94%) either agreed or strongly agreed that they found it convenient to receive treatment via an infusion, highlighting an overall positive experience with VYEPTI. In addition to the 94 patients, four HCPs were also surveyed, and reported they received positive feedback from their patients after receiving a VYEPTI infusion, consistent with the patient self-reported responses.

• Results from The Harris Poll Migraine Report Card Survey found disparities in migraine treatment in the U.S., especially for Black adults³
  A sub-analysis of The Harris Poll Migraine Report Card Survey, a U.S. population-based survey, evaluated self-reported race/ethnicity-based similarities and differences in 414 adults (White, n=293; Black, n=46; Hispanic, n=75) with high-frequency headache/migraine (HFM) and acute medication overuse (AMO), defined as at least eight days per month with headache with at least 10 days per month of acute headache medication use.
  
  Results from the survey found disparities in migraine treatment, such as the usage of preventive medication, as well as the perceptions of care, in adults with HFM+AMO grouped by self-reported race and ethnicity, especially for Black adults. Specifically, White respondents were more likely than Black and Hispanic respondents to currently use a preventive (20%, 7% and 10% respectively) or acute migraine treatment (44%, 40% and 26% respectively). Black respondents were more likely to report that they were “very concerned” about their current health compared to White and Hispanic respondents (54%, 29% and 24%, respectively; P<0.05). White respondents were more likely to feel that they made decisions together with their HCP about treatment options when compared to Hispanic respondents (47% vs. 31% Hispanic; P<0.05).

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

• Poster #89: Headache-Related Stigma in Adults Experiencing High-Frequency Headache/Migraine and High Acute Medication Use: Results of The Harris Poll Migraine Report Card Survey⁴
• Poster #90: Health Concerns and Treatment Perspectives Among U.S. Adults With Current Versus Previous High-Frequency Headache/Migraine and Acute Medication Overuse: The Harris Poll Migraine Report Card Survey⁵
• Poster #114: Long-Term Effectiveness of Eptinezumab-jjmr in Patients With Prior Preventive Migraine Treatment Failures⁶
• Poster #115: Long-Term Effectiveness of Eptinezumab-jjmr in Treatment of Patients With Chronic Migraine and Medication-Overuse Headache⁷
• Poster #137: Patient Awareness and Provider Communication about Medication-Overuse Headache Among Patients with Migraine⁸
• Poster #144: Persistence to OnabotulinumtoxinA or Calcitonin Gene-Related Peptide Monoclonal Antibody Therapy Among Patients With Migraine: A Retrospective Cohort Study⁹

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 (in Español) and Patient Information or visit www.VYEPTIHCP.com.

About Migraine

Migraine is a complex and disabling neurological disorder that limits functionality and quality of life.¹⁰ 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.^10,11 Over time, migraine may worsen, with attacks increasing in frequency, severity, and duration.^12,13 It is estimated to affect approximately 39 million people in the U.S. and impacts three times as many women than men.¹⁰ Headache disorders, of which migraine comprised 88.2%, is a leading cause of years lived with disability (YLD) among all diseases and is the #5 YLD cause among people aged 25-49 years, according to the Global Burden of Disease study.¹⁴ The impact of migraine permeates into career, home life and relationships.¹⁵ More than 157 million workdays are lost each year in the U.S. due to migraine.¹⁶

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 REVIEW Study

Real-world Evidence and Insights into Experiences With eptinezumab-jjmr (REVIEW) is an observational, multi-site (n=4), U.S.-based study that evaluated 94 patients treated with VYEPTI for chronic migraine (CM) in the outpatient setting and 4 principal investigators. Patients included in the study were greater than or equal to 18 years of age and had at least 2 consecutive cycles of VYEPTI infusions (i.e., 6 months of exposure). The study consisted of a retrospective chart review, a patient survey and a semi-structured healthcare provider interview. The REVIEW study aimed to provide a comprehensive understanding of the real-world experiences with VYEPTI from physician and patient perspectives.

About Lundbeck

Lundbeck LLC is a wholly owned subsidiary of H. Lundbeck A/S (HLUNa / HLUNb, HLUNA DC / HLUNB DC), 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 have approximately 5,400 employees in more than 50 countries, and our products are available in more than 100 countries. 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. We have research facilities in Denmark and the United States, and our production facilities are located in Denmark, France and Italy.

In the United States, H. Lundbeck A/S subsidiaries, including Lundbeck LLC, employ more than 1,000 people focused solely on accelerating therapies for brain disorders. With a special commitment to the lives of patients, families and caregivers, Lundbeck US actively engages in a broad range of initiatives each year that support patient communities.

For additional information, we encourage you to visit us at lundbeck.com/us and connect with us on LinkedIn and Twitter at @LundbeckUS.

References

¹ Argoff C, et al. Real-world evidence of the effectiveness and satisfaction with eptinezumab treatment in patients with chronic migraine. Available at (2023), American Headache Society 65 Annual Scientific Meeting June 15-18, 2023 Austin, Texas. Headache, 63: 1-205. https://doi.org/10.1111/head.14523.
² Argoff C, et al. Patients and physicians report a positive infusion experience with eptinezumab in the real-world setting. Available at (2023), American Headache Society 65 Annual Scientific Meeting June 15-18, 2023 Austin, Texas. Headache, 63: 1-205. https://doi.org/10.1111/head.14523.
³ Starling AJ, et al. Race/ethnicity-based perceptions of and experience with migraine-related burden, treatment, and care in people with high-frequency headache/migraine and high acute medication use. Available at (2023), American Headache Society 65 Annual Scientific Meeting June 15-18, 2023 Austin, Texas. Headache, 63: 1-205. https://doi.org/10.1111/head.14523.
⁴ Buse DC, et al. Headache-Related Stigma in Adults Experiencing High-Frequency Headache/Migraine and High Acute Medication Use: Results of the Harris Poll Migraine Report Card Survey. Available at (2023), American Headache Society 65 Annual Scientific Meeting June 15-18, 2023 Austin, Texas. Headache, 63: 1-205. https://doi.org/10.1111/head.14523.
⁵ Starling A, 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 (2023), American Headache Society 65 Annual Scientific Meeting June 15-18, 2023 Austin, Texas. Headache, 63: 1-205. https://doi.org/10.1111/head.14523.
⁶ Starling AJ, et al. Long-term effectiveness of eptinezumab in patients with prior preventive migraine treatment failures. Available at (2023), American Headache Society 65 Annual Scientific Meeting June 15-18, 2023 Austin, Texas. Headache, 63: 1-205. https://doi.org/10.1111/head.14523.
⁷ Blumenfeld A, et al. Long-term effectiveness of eptinezumab in treatment of patients with chronic migraine and medication-overuse headache. Available at (2023), American Headache Society 65 Annual Scientific Meeting June 15-18, 2023 Austin, Texas. Headache, 63: 1-205. https://doi.org/10.1111/head.14523.
⁸ Curran Y, et al. Patient Awareness and Provider Communication about Medication-Overuse Headache among Patients with Migraine. Available at (2023), American Headache Society 65 Annual Scientific Meeting June 15-18, 2023 Austin, Texas. Headache, 63: 1-205. https://doi.org/10.1111/head.14523.
⁹ 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 (2023), American Headache Society 65 Annual Scientific Meeting June 15-18, 2023 Austin, Texas. Headache, 63: 1-205. https://doi.org/10.1111/head.14523.
¹⁰ American Migraine Foundation. Migraine: Find out the symptoms, causes, and treatments of this disabling neurological disease. Available at https://americanmigrainefoundation.org/resource-library/what-is-migraine/#:~:text=The%20American%20Migraine%20Foundation%20estimates,actual%20number%20is%20probably%20higher. Accessed May 1, 2023.
¹¹ National Institute of Neurological Disorders and Stroke. Migraine. Available at: https://www.ninds.nih.gov/health-information/disorders/migraine. Accessed May 1, 2023.
¹² GBD 2019 Diseases and Injuries Collaborators. 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. Lancet. 2020 Oct 17;396(10258):1204-1222.
¹³ American Headache Society. Headache 2019; 59: 1–18
¹⁴ Steiner TJ, et al. Migraine is first cause of disability in under 50s: will health politicians now take notice? J Headache Pain. 2018;19(1):17
¹⁵ Buse DC, Fanning KM, Reed ML, et al. Life With Migraine: Effects on Relationships, Career, and Finances From the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study. Headache. 2019;59(8):1286-1299. doi: https://doi.org/10.1111/head.13613
¹⁶ National Headache Foundation. Migraine Facts. Available at: https://headaches.org/migraine-facts/. Accessed May 1, 2023.

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