Lundbeck to Present Data on VYEPTI® (eptinezumab-jjmr) at the 64th Annual Scientific Meeting of the American Headache Society, Furthering Clinical and Real-World Evidence for Migraine Prevention

• Nine poster presentations reinforce the scientific evidence for eptinezumab as a preventive migraine treatment in adults
• Two separate post-hoc analyses from the pivotal PROMISE-1 and PROMISE-2 studies showed eptinezumab was associated with fewer monthly headache days vs. placebo across 6 months of treatment, and subsequent dosing of eptinezumab may provide benefits for patients who initially have suboptimal response, respectively
• Results from new subpopulation analysis of the Phase 3b DELIVER study support the efficacy and safety profile of eptinezumab

DEERFIELD, Ill., June 9, 2022 – Lundbeck today announced data on VYEPTI® (eptinezumab-jjmr) will be presented at the 64^th Annual Scientific Meeting of the American Headache Society (AHS) taking place from June 9-12, 2022. A total of nine poster presentations will be shared to highlight clinical data and real-world analyses of eptinezumab as a preventive migraine treatment in adults.

“These data continue to show the clinical benefit of VYEPTI as a preventive treatment option for people with migraine,” said Marija Geertsen, M.D., Vice President, U.S. Medical Affairs, Lundbeck. “We remain committed to evolving and improving migraine care for those who are highly impacted by migraine and seeking different options to help break the vicious cycle of increasing migraine attacks and more acute treatment use.”

Key abstracts include:

• Treatment with eptinezumab resulted in downward shift in diagnostic frequency category
  A post-hoc analysis of the pivotal Phase 3 studies of eptinezumab for migraine prevention in adults with episodic (PROMISE-1) or chronic migraine (PROMISE-2) looked at the proportions of patients with a reduction from baseline of headache frequency following the first 6 months of treatment with eptinezumab. Headache frequency was categorized into 4 groups based on monthly headache days (MHDs): chronic migraine (≥15 MHDs), high-frequency episodic migraine (10–14 MHDs), low-frequency episodic migraine (4–9 MHDs), and very-low-frequency episodic migraine (≤3 MHDs). In both PROMISE-1 and PROMISE-2 studies, treatment with eptinezumab resulted in a sustained downward shift in diagnostic frequency of episodic and chronic migraine across two dosing intervals. In total, for PROMISE-1, 35.8% (100mg, 79/221), 37.4% (300mg, 83/222), and 30.6% (placebo, 68/222) of patients had 6 months with reduction of at least one diagnostic category. In total, for PROMISE-2, 43.0% (100mg, 153/356), 48.3% (300mg, 169/350), and 31.7% (placebo, 116/366) of patients had 6 months with reduction of ≥1 diagnostic category.

• Subsequent dose of eptinezumab showed benefit for patients initially reporting suboptimal response
  A post-hoc analysis of the pivotal Phase 3 PROMISE-1 and PROMISE-2 studies assessed predictors of a second-dose response to eptinezumab treatment for the prevention of migraine over weeks 13-24 in patients who initially reported a suboptimal first-dose response (<50% monthly migraine day [MMD] reduction) to eptinezumab over weeks 1-12. The analysis showed in both PROMISE studies, a second dose of eptinezumab may be beneficial for patients with episodic or chronic migraine who did not experience ≥50% reduction in MMDs with their first dose of eptinezumab. The proportion of suboptimal first-dose responders who were second-dose responders was 37.0% (71/192) with eptinezumab and 33.9% (42/124) with placebo in PROMISE-1, and 28.8% (79/274) with eptinezumab and 18.5% (38/205) with placebo in PROMISE-2. First-dose predictors of second-dose response were percent change in MMDs across weeks 1–12 and change in 6-item Headache Impact Test (HIT-6) total score (PROMISE-2, only).

• Migraine Prevention in Patients with Prior Treatment Failures
  This exploratory subpopulation analysis of the Phase 3b DELIVER study evaluated the efficacy and safety of eptinezumab for the prevention of migraine in patients with 2-4 previous preventive treatment failures. Prespecified patient subgroups included medication-overuse headache (MOH) diagnosis, disease classification, number of previous treatment failures, and sex. Patients treated with eptinezumab demonstrated larger reductions in MMDs from baseline through week 12 than patients receiving placebo across all subgroups. Mean MMDs for patients with episodic migraine decreased by 3.1 days (100mg; n=162) and 4.0 days (300mg; n=158) versus 1.0 day for placebo (n=164). For patients with chronic migraine, mean MMDs decreased by 6.5 days (100mg; n=137) and 6.6 days (400mg; n=134) versus 3.3 days for placebo (n=134). And, for patients with medication overuse headache, mean MMDs decreased by 5.6 days (100mg; n=38) and 7.3 days (300mg; n=35) versus 2.3 days (placebo; n=37). The safety profile of eptinezumab was consistent with the safety profile observed in the pivotal Phase 3 PROMISE-1 and PROMISE-2 studies of eptinezumab for the preventive treatment of migraine in adults.

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.

“As a physician treating migraine patients every day, it is great to see the growing real-world and clinical evidence supporting the role eptinezumab can play in migraine prevention,” said Paul K. Winner, DO, FAAN, FAHS, Palm Beach Headache Center. “These data contribute to our long-term understanding of VYEPTI and the people who may benefit from this treatment.”

The full range of eptinezumab-related data to be presented by Lundbeck at AHS 2022 is listed below.

• Abstract #1195807: Efficacy and Safety of Eptinezumab for Migraine Prevention in Patients With 2–4 Prior Preventive Treatment Failures (poster).
• Abstract #1191583: Eptinezumab for Migraine Prevention in Patients with 2-4 Prior Treatment Failures: DELIVER Subpopulation Analysis (poster).
• Abstract #1196008: Optimization of Acute Treatment and Headache-Related Impact Following Eptinezumab Initiated During a Migraine Attack: Post Hoc Analysis of the RELIEF Study (poster).
• Abstract #1196040: Change in Migraine Diagnosis After Preventive Treatment with Eptinezumab: Post Hoc Analysis of the PROMISE Studies (poster).
• Abstract #1196072: Patient Preferences for Attributes of Advanced Migraine Prevention Medications: Findings from a Discrete Choice Experiment (poster).
• Abstract #1196574: Measuring Dose-Related Efficacy of Eptinezumab for Migraine Prevention: Post Hoc Analysis of PROMISE-1 and PROMISE-2 (poster).
• Abstract #1196684: Likelihood of Response with Subsequent Dosing for Patients with Migraine and Initial Suboptimal Response with Eptinezumab (poster).
• Abstract #1196738: Early Clinical Experience with Eptinezumab from a Retrospective, Observational Study of Real-World Patient Response (poster).
• Abstract #1196756: Development and validation of a novel model for characterizing migraine outcomes within electronic health records utilizing artificial intelligence (poster).
  
  

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.

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 primary endpoint was met in both episodic and chronic migraine. 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.

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 and Important Safety Information

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, and rash, have occurred with VYEPTI in clinical trials. 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 Prescribing Information and Patient Information or visit www.VYEPTIHCP.com

About the DELIVER Study

DELIVER (NCT04418765) is a Phase 3b, multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of VYEPTI 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 per month and headache occurring on ≤14 days. All patients had to have experienced failures of two to four prior preventive treatment classes. Patient 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 record or by physician's confirmation specific to each treatment in the past 10 years.

In the study, 892 patients were randomized to receive eptinezumab 100mg or 300mg or placebo by intravenous (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 for patients with 50% or greater reduction from baseline in MMDs (weeks 1–12), response rates for 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 VYEPTI 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, Health care resources utilization (HCRU), and Work Productivity and Activity Impairment Questionnaire (WPAI).

About Migraine

Migraine is a complex and incapacitating neurological disease characterized by recurrent episodes of severe headaches typically accompanied by an array of symptoms, including nausea, vomiting, and sensitivity to light or sound.1 It is estimated to affect approximately 39 million people in the U.S. and more than 1.3 billion worldwide, 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.² Migraine has a profound impact on peoples’ lives, their relationships, as well as their ability to carry out activities of daily living.³ More than 157 million workdays are lost each year in the U.S. due to migraine.¹

Contact

Brittany Korb
Senior Manager, Brand Communications
brkr@lundbeck.com

About Lundbeck

H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY) is a global biopharmaceutical 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.

Our approximately 5,300 employees in more than 50 countries are engaged in the entire value chain throughout research, development, production, marketing and sales. Our pipeline consists of several R&D programs and our products are available in more than 100 countries. We have research centers in Denmark and California and our production facilities are located in Denmark, France and Italy.

In the United States, Lundbeck employs 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 our patient communities.

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

References

1. Migraine Research Foundation. Migraine Facts. Available at https://migraineresearchfoundation.org/about-migraine/migraine-facts/. Accessed February 23, 2022.
2. Steiner TJ, Stovner LJ, Vos T, Jensen R, Katsarava Z. Migraine is first cause of disability in under 50s: will health politicians now take notice? J Headache Pain. 2018;19(1):17.
3. Lipton RB, Bigal ME, Diamond M, et al. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology 2007;68:343-349.