POWERFUL. FAST. SUSTAINED. RESULTS.1,2
VYEPTI is proven to reduce monthly migraine days (MMD) in patients with ≥4 MMD.3
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PROMISE-1 study design
Episodic migraine (4 to 14 MHD, of which at least 4 were migraine days)3*
PROMISE-1 was a parallel-group, double-blind, placebo-controlled global trial to evaluate the efficacy and safety of VYEPTI for the preventive treatment of episodic migraine in adults. A total of 665 patients were randomized and received placebo (n=222), VYEPTI 100 mg (n=221), or VYEPTI 300 mg (n=222) every 3 months for 12 months.4
*One month was defined as 28 consecutive days.5
MHD, monthly headache days.
PROMISE-2 study design
Chronic migraine (≥15 MHD, of which ≥8 were migraine days)3*
PROMISE-2 was a parallel-group, double-blind, placebo-controlled global trial to evaluate the efficacy and safety of VYEPTI for the preventive treatment of chronic migraine in adults. A total of 1072 patients were randomized and received placebo (n=366), VYEPTI 100 mg (n=356), or VYEPTI 300 mg (n=350) every 3 months for 6 months.6
*One month was defined as 28 consecutive days.6
MHD, monthly headache days.
After a single dose of VYEPTI 100 mg, patients had fewer migraine days, on average, over 3 months3
Primary endpoint: Mean change from baseline in mean MMD (Months 1-3)3
Episodic migraine
Chronic migraine
*p=0.018 vs placebo.3
✝︎Analysis of covariance model used to test for difference between treatment groups.4,6
‡p<0.001 vs placebo.3
MMD, monthly migraine days.
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IMPORTANT SAFETY INFORMATION
AND INDICATION
Contraindications
VYEPTI is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of the excipients. Reactions have included anaphylaxis and angioedema.
INDICATION
VYEPTI is indicated for the preventive treatment of migraine in adults.
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.
For more information, please see the Full Prescribing Information and Patient Information.
IMPORTANT SAFETY INFORMATION
AND INDICATION
Contraindications
VYEPTI is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of the excipients. Reactions have included anaphylaxis and angioedema.
INDICATION
VYEPTI is indicated for the preventive treatment of migraine in adults.
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.
For more information, please see the Full Prescribing Information and Patient Information.
References:
- Baker 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.
- Garcia-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.
- VYEPTI (eptinezumab-jjmr) [package insert]. Bothell, WA: Lundbeck Seattle BioPharmaceuticals, Inc.
- Ashina 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.
- Data on file. Bothell, WA: Lundbeck Seattle BioPharmaceuticals, Inc.
- Lipton 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.
© 2023 Lundbeck. All rights reserved. VYEPTI and VYEPTI GO are registered trademarks, and VYEPTI CONNECT and Migraine Victors Program are trademarks of Lundbeck Seattle BioPharmaceuticals, Inc. EPT-B-100032v14
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