Lundbeck to Present Data on Migraine Impact Reduction and Sustained Response with VYEPTI® (eptinezumab-jjmr) at 76th Annual Meeting of the American Academy of Neurology

• New clinical and real-world data presented across one oral and four poster presentations at AAN 2024 underscore Lundbeck’s commitment to evolving migraine care
  
• Oral presentation of new post-hoc analysis from Phase 3 DELIVER study reveals early clinical response to VYEPTI associated with continued response for up to 18 months
• Observational data demonstrate real-world effectiveness of VYEPTI with brain fog improvement, which was associated with increased number of “good” days per month  

DEERFIELD, Ill., April 9, 2024 – Lundbeck US, the US subsidiaries of H. Lundbeck A/S, will present new data for VYEPTI® (eptinezumab-jjmr), an anti-CGRP monoclonal antibody for the preventive treatment of migraine, including a post-hoc analysis of the Phase 3 DELIVER study that found most patients who responded to treatment within one to two doses maintained treatment response over 18 months. These data will be presented during an oral session at the 76^th Annual Meeting of the American Academy of Neurology (AAN) taking place in Denver, Colo., and virtually from April 13-18, 2024.

This analysis (Program #: S22.008) shows that among patients with ≥50% response (>50% reduction from baseline in monthly migraine days [MMDs]) over the first dosing interval (weeks 1-12), 74% of patients (93/126) taking VYEPTI 300 mg maintained their response for the entire 18-month treatment period of the study.¹ Additionally, of the patients with ≥50% response over the first two dosing intervals (weeks 1-24), 82% of patients (107/131) taking VYEPTI 300 mg maintained their response over the study duration.¹

“The Phase 3 DELIVER study demonstrated sustained response to eptinezumab-jjmr preventive migraine treatment, including reductions in the frequency and severity of migraine, and acute medication use, as well as patient-reported improvements in functioning and health-related quality of life,”^2,3 said Jessica Ailani, MD, Professor of Clinical Neurology at Georgetown University School of Medicine. “The post-hoc analysis further supports these findings with the insight that an early response to eptinezumab-jjmr treatment was associated with a maintenance of treatment response over 18 months.”¹

Analyses from Real-world Evidence and Insights into Experiences With eptinezumab-jjmr (REVIEW) will also be presented at AAN and revealed a strong correlation between “good” days and improvement in brain fog as associated with migraine.^4,5,6 Additionally, patients reported an increase of ~10 “good” days per month irrespective of psychiatric comorbidities.^4,5,6 The observational REVIEW study used a retrospective chart review, patient survey and physician interview to assess real-world experiences among 94 patients with chronic migraine who had received at least two doses of VYEPTI in the clinical setting.^4,5,6

“People who are highly impacted by migraine are often robbed of the quality of life they deserve,” said Damian Fiore, Vice President, US Medical Affairs Neurology. “Our real-world data helps us better understand how individuals are uniquely impacted by migraine beyond monthly headache days. We’re excited to continually partner with the migraine community to raise the bar on preventive treatment expectations.”

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 findings from additional abstracts include:

• VYEPTI led to sustained improvement in monthly headache days (MHDs) from baseline among most patients with chronic migraine in Phase 3 study (Program #: P5.010)⁷ In a post-hoc analysis from the Phase 3 DELIVER study, VYEPTI treatment resulted in more patients with <4 MHDs compared to placebo (24 weeks), and most patients with chronic migraine at baseline no longer met diagnostic criteria for chronic migraine after 72 weeks of treatment.
  
  
• Two-fold increase in average “good” days per month with VYEPTI, regardless of prior anti-CGRP mAb treatment (Program #: P8.004)⁴ A post-hoc analysis from the observational REVIEW study showed that chronic migraine patients (n=94) had high overall satisfaction with VYEPTI regardless of the number and type of previous subcutaneous anti-CGRP monoclonal antibody (mAb) therapies used. Patients reported a similar increase in the number of “good” days per month, from a mean of 8 before VYEPTI to 18 following treatment, regardless of prior exposure to anti-CGRP mAb treatment. “Good” days are associated with VYEPTI treatment and migraine.
  
  
• Chronic migraine patients treated with VYEPTI reported improvements in brain fog and the number of good days in a real-world setting (Program #: P8.009)⁵ A post-hoc analysis from the observational REVIEW study found that among 94 patients with chronic migraine, brain fog was commonly reported (80%) and identified as a very/extremely bothersome symptom. Among those with brain fog, 86% reported some level of brain fog improvement (a symptom of migraine defined as feeling confused, having difficulty learning or remembering, or having trouble speaking or reading) and 63% reported moderate to complete improvement with VYEPTI treatment.
  
  
• Real-world effectiveness of VYEPTI in patients with chronic migraine not impacted by the presence of psychiatric conditions (Program #: P4.005)⁶ A post-hoc analysis from the observational REVIEW study demonstrated the real-world effectiveness of VYEPTI regardless of the presence or absence of self-reported psychiatric conditions that are common in patients with migraine, including anxiety, depression and bipolar disorder. A mean increase of ~10 “good” days per month (from 8 to 18 days) was reported with VYEPTI treatment among 94 patients, including in 65% (61/94) with self-reported psychiatric conditions. “Good” days are associated with VYEPTI treatment and migraine. The safety and efficacy of VYEPTI has not been evaluated for use in any psychiatric conditions.

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 intravenous (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 Migraine
Migraine is a complex and disabling neurological disorder that limits functionality and quality of life.⁸ 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.^8,9 Over time, migraine may worsen, with attacks increasing in frequency, severity and duration.^10,11 It is estimated to affect approximately 39 million people in the U.S., and impacts three times as many women than men.⁸ 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.¹² The impact of migraine permeates into career, home life and relationships.¹³ More than 157 million workdays are lost each year in the U.S. due to migraine.¹⁴

About the DELIVER study
DELIVER (NCT04418765) is a phase lllb, 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 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 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 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, healthcare resources utilization (HCRU), and Work Productivity and Activity Impairment Questionnaire (WPAI).

The safety and tolerability of VYEPTI in the DELIVER study were similar to placebo and consistent with findings from previous VYEPTI clinical trials. In DELIVER and earlier VYEPTI studies, upper respiratory tract infection, nasopharyngitis, dizziness, and fatigue were the most commonly reported treatment-emergent adverse events (TEAEs).

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 with 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.

Contact
Brittany Korb
Director, Product Communications and Patient Advocacy
brkr@lundbeck.com

About Lundbeck
Lundbeck US refers to the wholly owned US subsidiaries of H. Lundbeck A/S (HLUNa / HLUNb, HLUNA DC / HLUNB DC) (“Lundbeck”), a global pharmaceutical company specialized in brain diseases, including Lundbeck LLC and Lundbeck Pharmaceuticals LLC. 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 X @LundbeckUS.

References

1.Ailani J, et al. Long-term maintenance of ≥50% migraine response with eptinezumab treatment in patients with 2–4 prior preventive migraine treatment failures. Available at https://index.mirasmart.com/AAN2024/PDFfiles/AAN2024-002487.html. Accessed March 28, 2024. 

2.Ashina, M., et al. Safety and efficacy of eptinezumab for migraine prevention in patients with two-to-four previous preventive treatment failures (DELIVER): a multi-arm, randomised, double-blind, placebo-controlled, phase 3b trial. Lancet Neurol. 7, 21 (2022). https://doi.org/10.1016/S1474-4422(22)00185-5

3. Ashina, M., et al. Long-term effectiveness of eptinezumab in patients with migraine and prior preventive treatment failures: extension of a randomized controlled trial. J Headache Pain 24, 155 (2023). https://doi.org/10.1186/s10194-023-01688-w

4. Argoff C, et al. Real-world effectiveness of intravenous eptinezumab in patients with chronic migraine and previous subcutaneous preventive migraine treatment. Available at https://index.mirasmart.com/AAN2024/PDFfiles/AAN2024-002528.html. Accessed March 28, 2024. 

5. Buse DC, et al. Treatment with eptinezumab reduces brain fog and increases the number of good days per month in patients with chronic migraine in a real-world setting. Available at https://index.mirasmart.com/AAN2024/PDFfiles/AAN2024-002495.html. Accessed March 28, 2024. 

6. Argoff C, et al. Impact of psychiatric conditions on the real-world effectiveness of eptinezumab treatment in patients with chronic migraine. Available at https://index.mirasmart.com/AAN2024/PDFfiles/AAN2024-002525.html. Accessed March 28, 2024.   

7. Starling AJ, et al. Shift in MHDs below the threshold of preventive optimization after eptinezumab treatment in patients with migraine and history of 2–4 preventive migraine treatment failures. Available at https://index.mirasmart.com/AAN2024/PDFfiles/AAN2024-002540.html. Accessed March 28, 2024.   

8. 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 March 28, 2024.

9. National Institute of Neurological Disorders and Stroke. Migraine. Available at: https://www.ninds.nih.gov/health-information/disorders/migraine. Accessed March 28, 2024.

10. GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016 [published correction] appears in Lancet. 2017;390(10100):1211-1259.

11. American Headache Society. Headache 2019; 59: 1–18

12 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

13. 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

14. National Headache Foundation. Migraine Facts. Available at: https://headaches.org/migraine-facts/. Accessed March 28, 2024.