DEERFIELD, Ill., June 15, 2023 – Lundbeck today announced new VYEPTI® (eptinezumab-jjmr) data will be presented at the 65th 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 16th 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:
Additional data to be presented by Lundbeck at AHS 2023 is listed below.
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.
VYEPTI® (eptinezumab-jjmr) is indicated for the preventive treatment of migraine in adults.
Important Safety Information
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.
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.
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.14The 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.
Associate Director, Product and Business Unit Communications
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.
1 Argoff C, et al. Real-world evidence of the effectiveness and satisfaction with eptinezumab treatment in patients with chronic migraine. Available at 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 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 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 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 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 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 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 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 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.