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This information is intended for U.S. healthcare professionals.
Migraine is a complex neurological disease characterized by recurrent episodes of severe, often incapacitating, headaches that also can be accompanied by an array of symptoms that can impact many aspects of life.1 The disease impacts an estimated 39 million Americans, but it may be managed with acute and preventive treatments.1, 2, 3, 4 Although prevention aims to reduce the frequency of attacks, many patients who qualify for prevention do not receive it.5, 6, 7, 8 Migraine treatment expectations may change with an emerging class of therapies targeting CGRP (calcitonin gene-related peptide), a neuropeptide believed to play a role in initiating migraine attacks and in disease progression.9, 10, 11, 12, 13
VYEPTI® (eptinezumab-jjmr) is the first and only intravenous (IV) CGRP antagonist for the preventive treatment of migraine in adults.14 VYEPTI offers sustained duration of action with strong binding to the CGRP ligand and minimal disassociation.15, 16, 17* While 100 mg is the recommended dose, some patients may benefit from 300 mg.14 VYEPTI is administered via a 30 minute IV infusion four times per year (every three months).14
VYEPTI Clinical Data
Two randomized, double-blind, placebo-controlled studies compared the efficacy and safety of VYEPTI 100 mg or 300 mg versus placebo.18, 19 One study (PROMISE 1) included 665 patients ages 18 to 75 years with episodic migraine – defined as 4 to 14 headache days per month (average 8.6 days at baseline) in which ≥4 were migraine days – treated every 3 months for 12 months.14, 18 The second study (PROMISE 2) included 1,072 patients ages 18 to 65 years with chronic migraine – defined as 15 to 26 headache days per month (average 16.1 days at baseline) of which at least 8 were migraine days – treated every 3 months for 6 months.14, 19 In both studies, the primary efficacy endpoint was a change from baseline in the mean monthly migraine days (MMDs) over Months 1 to 3.18, 19
With one 30-minute treatment every 3 months, VYEPTI can help patients meet their migraine- free potential.14,18,19 In both studies, VYEPTI significantly reduced MMDs starting with the first dose.18, 19
After a single dose of VYEPTI 100 mg, patients with episodic migraine reported 12 fewer migraine days, on average, over Months 1 to 3 (vs. 9 fewer with placebo).18 During this same time period, patients with chronic migraine had, on average, 23 fewer migraines (vs. 16 fewer with placebo).19 About a quarter of the patients treated with VYEPTI 100 mg (22%, episodic; 27%, chronic) experienced at least 75% fewer migraine days over Months 1 to 3 (vs. 16.2%, episodic; 15%, chronic placebo respectively).18, 19 Approximately 1 in 3 chronic migraine patients experienced a 75% reduction in migraine days in the first 6 months.20
During a 6-month study period, 35% of patients with chronic migraine treated with VYEPTI 100 mg were migraine-free for a month or more versus 22% on placebo.21 Among patients with episodic migraine, 63% treated with VYEPTI 100 mg were migraine-free for a month or more versus 48% with placebo during a 12-month study period.21
VYEPTI was generally well tolerated with a safety comparable to placebo.14 The most common adverse reactions (≥2% and ≥2% than placebo) were nasopharyngitis and hypersensitivity.14 Additional Important Safety Information are included below.
VYEPTI delivers robust and sustained efficacy for migraine prevention that patients can count on, offering the potential for more migraine free days.14
For more information on migraine prevention and VYEPTI, visit VYEPTIhcp.com
*The relationship between the pharmacodynamic activity and the mechanism(s) by which eptinezumab-jjmr exerts its clinical effects is unknown.14
Indication and Important Safety Information
INDICATION
VYEPTI 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.
For more information, please see the Full Prescribing Information and Patient Information or go to VYEPTIhcp.com
© 2021 Lundbeck. All rights reserved. VYEPTI is a registered trademark of Lundbeck Seattle BioPharmaceuticals, Inc. EPT-B-100248v2
References
1 Migraine Research Foundation. Migraine Facts. Available at https://migraineresearchfoundation.org/about- migraine/migraine-facts/. Accessed April 28, 2021.
2Ferrari A, Baraldi C, Sternieri E. Medication overuse and chronic migraine: a critical review according to clinical pharmacology. Expert Opin Drug Metab Toxicol. 2015;11(7):1127-1144. doi:10.1517/17425255.2015.1043265
3Do TP, Guo S, Ashina M. Therapeutic novelties in migraine: new drugs, new hope? J Headache Pain. 2019;20(1):37. Published 2019 Apr 17. doi:10.1186/s10194-019-0974-3
4Diener H-C, Holle-Lee D, Nägel S, et al. Treatment of migraine attacks and prevention of migraine: Guidelines by the German Migraine and Headache Society and the German Society of Neurology. Clinical and Translational Neuroscience. January 2019. doi:10.1177/2514183X18823377
5American Headache Society. The American Headache Society Position Statement On Integrating New Migraine Treatments Into Clinical Practice. Headache. 2019;59(1):1-18. doi:10.1111/head.13456
6Diamond S, Bigal ME, Silberstein S, Loder E, Reed M, Lipton RB. Patterns of diagnosis and acute and preventive treatment for migraine in the United States: results from the American Migraine Prevalence and Prevention study. Headache. 2007;47(3):355-363. doi:10.1111/j.1526-4610.2006.00631.x
7Blumenfeld AM, Bloudek LM, Becker WJ, et al. Patterns of use and reasons for discontinuation of prophylactic medications for episodic migraine and chronic migraine: results from the second international burden of migraine study (IBMS-II). Headache. 2013;53(4):644-655. doi:10.1111/head.12055
8Lipton RB, Munjal S, Alam A, et al. Migraine in America Symptoms and Treatment (MAST) Study: Baseline Study Methods, Treatment Patterns, and Gender Differences. Headache. 2018;58(9):1408-1426. doi:10.1111/head.13407
9Lipton RB et al. Expert perspectives – migraine prevention for highly impacted patients. US Neurology.2018;14(Suppl.2):3–10.
10Deen M, Correnti E, Kamm K, et al. Blocking CGRP in migraine patients – a review of pros and cons. J Headache Pain. 2017;18(1):96. Published 2017 Sep 25. doi:10.1186/s10194-017-0807-1
11Moriarty M et al. Monoclonal Antibodies to CGRP or Its Receptor for Migraine Prevention. J Nurse Pract 2019; 15:717– 724
12Villalón CM, Olesen J. The role of CGRP in the pathophysiology of migraine and efficacy of CGRP receptor antagonists as acute antimigraine drugs. Pharmacol Ther. 2009;124(3):309-323. doi:10.1016/j.pharmthera.2009.09.003
13Ashina M. Migraine. N Engl J Med. 2020;383(19):1866-1876. doi:10.1056/NEJMra1915327
14VYEPTI (eptinezumab-jjmr) [package insert]. Bothell, WA: Lundbeck Seattle BioPharmaceuticals, Inc.
15Baker B, Schaeffler B, Beliveau M, et al. Population pharmacokinetic and exposure-response analysis of eptinezumab in the treatment of episodic and chronic migraine. Pharmacol Res Perspect. 2020;8(2):e00567. doi:10.1002/prp2.567
16Landry JP, Ke Y, Yu GL, Zhu XD. Measuring affinity constants of 1450 monoclonal antibodies to peptide targets with a microarray-based label-free assay platform. J Immunol Methods. 2015;417:86-96. doi:10.1016/j.jim.2014.12.011
17Garcia-Martinez LF, Raport CJ, Ojala EW, et al. Pharmacologic Characterization of ALD403, a Potent Neutralizing Humanized Monoclonal Antibody Against the Calcitonin Gene-Related Peptide. J Pharmacol Exp Ther. 2020;374(1):93-103. doi:10.1124/jpet.119.264671
18Ashina M, Saper J, Cady R, et al. Eptinezumab in episodic migraine: A randomized, double-blind, placebo-controlled study (PROMISE-1). Cephalalgia. 2020;40(3):241-254. doi:10.1177/0333102420905132
19Lipton RB, Goadsby PJ, Smith J, et al. Efficacy and safety of eptinezumab in patients with chronic migraine: PROMISE-2. Neurology. 2020;94(13):e1365-e1377. doi:10.1212/WNL.0000000000009169
20Silberstein S, Diamond M, Hindiyeh NA, et al. Eptinezumab for the prevention of chronic migraine: efficacy and safety through 24 weeks of treatment in the phase 3 PROMISE-2 (Prevention of migraine via intravenous ALD403 safety and efficacy-2) study. J Headache Pain. 2020;21(1):120. Published 2020 Oct 6. doi:10.1186/s10194-020-01186-3
21Winner P et al. Migraine-free months in patients with episodic or chronic migraine treated with eptinezumab results from the PROMISE-1 and PROMISE-2 trials. Presented at: American Headache Society (AHS) 61st Annual Scientific Meeting: Philadelphia, PA; July 11-14, 2019.