VYEPTI for episodic migraine

Explore the results:

Episodic Results

4 to 14 headache days per month, of which ≥4 were migraine days.1†

FAST

Early benefit seen within the first 7 days, and as soon as Day 1 post-infusion1‡

POWERFUL

Over 20% of patients experienced at least 75% fewer migraine days during Months 1-3 (22.2% vs 16.2% with placebo, not significant)1†

SUSTAINED

Reduced mean monthly migraine days by ~50% through Month 6 (vs 28-42% with placebo)1,2§¶

*Data from VYEPTI 100 mg dose groups.1

†One month was defined as 28 consecutive days.2

‡Data represent mean percent of patients based on observed data.1

§This is a prespecified endpoint but not prespecified analyses.2

¶Calculated from the percent change from baseline; percentages for VYEPTI range from 43-55%.2

Chronic Results

≥15 to ≤26 headache days per month, of which ≥8 were migraine days.1†

FAST

Early benefit seen within the first 7 days, and as soon as Day 1 post-infusion1‡

POWERFUL

~27% of patients on VYEPTI experienced at least 75% fewer migraine days during Months 1-3 (26.7% vs 15% with placebo, p<0.001)1†

SUSTAINED

Reduced mean monthly migraine days by ~50% through Month 6 (vs 30-39% with placebo)1,2§¶

*Data from VYEPTI 100 mg dose groups.1

†One month was defined as 28 consecutive days.7

‡Data represent mean percent of patients based on observed data.1

§This is a prespecified endpoint but not prespecified analyses.1

¶Calculated from the percent change from baseline; percentages for VYEPTI range from 47-54%.2

VYEPTI was also studied in patients with chronic migraine.

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.3

SEE STUDY DESIGN

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IV migraine treatment icon

VYEPTI is one
30-minute IV infusion every 3 months1

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 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, 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. 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 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 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, 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. 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 Prescribing Information and Patient Information.

References:
  1. VYEPTI (eptinezumab-jjmr) [package insert]. Bothell, WA: Lundbeck Seattle BioPharmaceuticals, Inc.
  2. Data on file. Bothell, WA: Lundbeck Seattle BioPharmaceuticals, Inc.
  3. 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. 
  4. Silberstein S, Kudrow D, Saper J, et al. Eptinezumab results for the prevention of episodic migraine over 1 year in the PROMISE-1 (PRevention Of Migraine via Intravenous Eptinezumab Safety and Efficacy–1) trial. Presented at: American Headache Society (AHS) Annual Meeting: San Francisco, CA; June 28-July 1, 2018. PF108LB.
  5. Saper J, Wilks K, Chakhava G, et al. Eptinezumab for the prevention of episodic migraine through 1 year: results from the phase 3 PROMISE-1 (PRevention Of Migraine via Intravenous Eptinezumab Safety and Efficacy–1) trial. Poster presented at: 71st American Academy of Neurology (AAN) Annual Meeting; May 4-10, 2019; Philadelphia, PA. 538.003.
  6. Winner P, McAllister P, Cady R, et al. Migraine-free months in patients with episodic or chronic migraine treated with eptinezumab: results from the PROMISE-1 and PROMISE-2 trials. Poster presented at: 61st Annual Scientific Meeting of the American Headache Society (AHS); July 11-14, 2019; Philadelphia, PA. P217LB.
  7. 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.