VYEPTI is indicated for the preventive treatment of migraine in adults. View patient site
VYEPTI is indicated for the preventive treatment of migraine in adults.

Review efficacy data from the VYEPTI pivotal trials

Change from baseline in mean monthly migraine days (weeks 1-12)2,3

 

VYEPTI 100 mg (n=356)

 

VYEPTI 300 mg (n=350)

 

Placebo (n=366)

Graph showing that after the first dose of VYEPTI 100 mg and 300 mg, patients with chronic migraine experienced a reduction in mean MMD by 7.7 and 8.2, respectively, vs 5.6 with placebo for weeks 1-12. Callout text: Patients experienced, on average, 24.6 fewer migraine days with dose 1 of VYEPTI 300 mg.

Change from baseline in mean monthly migraine days (weeks 1-12)2,3

 

VYEPTI 100 mg (n=356)

 

VYEPTI 300 mg (n=350)

 

Placebo (n=366)

Patients experienced, on average, 23.1 (VYEPTI 100 mg) and 24.6 (VYEPTI 300 mg) fewer migraine days over weeks 1-12 vs 16.8 with placebo* (baseline ~16.1 mean MMD; p<0.001 vs placebo).2,3†

*Calculated by multiplying the mean change from baseline in mean MMD by 3 months (VYEPTI 100 mg, 7.7; VYEPTI 300 mg, 8.2; placebo, 5.6).

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

VYEPTI 100 mg is the recommended dose. Some patients may benefit from the approved 300 mg dose.

MMD, monthly migraine days.

Patients had ≥15 to ≤26 headache days per month, of which ≥8 were migraine days.2

PROMISE-2 trial design graphic, showing screening for 28 days beginning at Week -4 and randomization into placebo (n=366), VYEPTI 100 mg (n=356), and VYEPTI 300 mg (n=350). IV treatments occurred at Week 0 and Week 12. The primary endpoint was measured at Week 12, and the study ended at Week 32.
PROMISE-22,3

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 1,072 patients were randomized and received placebo, VYEPTI 100 mg, or VYEPTI 300 mg every 12 weeks for 24 weeks
  • The study included patients with chronic migraine, some of whom had a dual diagnosis of medication overuse headache attributable to acute medication overuse
  • Primary endpoint: change from baseline in mean monthly migraine days over weeks 1-12

PROMISE, PRevention Of Migraine via Intravenous Eptinezumab Safety and Efficacy.

The study included:

  • Patients using an established stable regimen of acute migraine or headache prevention medication (except onabotulinumtoxinA)
  • Patients with a dual diagnosis of chronic migraine and medication overuse headache attributable to acute medication overuse (triptans, ergotamine, or combination analgesics >10 days per month)

The study excluded:

  • Patients using opioids or butalbital-containing products >4 days per month
  • Patients with a history of:
    • Cardiovascular disease (hypertension, ischemic heart disease)
    • Neurological disease
    • Cerebrovascular disease

Change from baseline in mean monthly migraine days (weeks 1-12)2,4

 

VYEPTI 100 mg (n=221)

 

VYEPTI 300 mg (n=222)

 

Placebo (n=222)

Graph showing that after the first dose of VYEPTI 100 mg* and 300 mg†, patients with episodic migraine experienced a reduction in mean MMD by 3.9 and 4.3, respectively, vs 3.2 with placebo for weeks 1-12. Patients experienced 12.9 fewer migraine days with VYEPTI 300 mg.☨ Callout text: Patients experienced, on average, 12.9 fewer migraine days with dose 1 of VYEPTI 300 mg.‡

Change from baseline in mean monthly migraine days (weeks 1-12)2,4

 

VYEPTI 100 mg (n=221)

 

VYEPTI 300 mg (n=222)

 

Placebo (n=222)

Patients experienced, on average, 11.7 (VYEPTI 100 mg)* and 12.9 (VYEPTI 300 mg)† fewer migraine days over weeks 1-12 vs 9.6 with placebo‡ (baseline ~8.6 mean MMD; p<0.001 vs placebo).2,4§

*p=0.018 vs placebo.

†p<0.001 vs placebo.

‡Calculated by multiplying the mean change from baseline in mean MMD by 3 months (VYEPTI 100 mg, 3.9; VYEPTI 300 mg, 4.3; placebo, 3.2).

§Episodic migraine: 4 to 14 headache days per month, of which ≥4 were migraine days.

VYEPTI 100 mg is the recommended dose. Some patients may benefit from the approved 300 mg dose.

MMD, monthly migraine days.

Patients had 4 to 14 headache days per month, of which ≥4 were migraine days.2

PROMISE-1 trial design graphic showing screening for 28 days beginning at Week –4 and randomization into placebo (n=222), VYEPTI 100 mg (n=221), and VYEPTI 300 mg (n=222). IV treatments occurred at Week 0, Week 12, Week 24, and Week 36. The primary endpoint was measured at Week 12, and the study ended at Week 56.
PROMISE-12,4

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, VYEPTI 100 mg, or VYEPTI 300 mg every 12 weeks for 56 weeks
  • The study also included a VYEPTI 30 mg (n=223) treatment arm, but is not an approved dose. VYEPTI 100 mg is the recommended dose. Some patients may benefit from the approved 300 mg dose
  • Primary endpoint: change from baseline in mean monthly migraine days over weeks 1-12

PROMISE, PRevention Of Migraine via Intravenous Eptinezumab Safety and Efficacy.

The study included:

  • Patients using concurrent acute migraine or headache medications, including migraine-specific medications (eg, triptans, ergotamine derivatives)

The study excluded patients with a history of:

  • Cardiovascular disease (hypertension, ischemic heart disease)
  • Neurological disease
  • Cerebrovascular disease

≥75% migraine responder rate5*

 

VYEPTI 300 mg (n=350)

 

Placebo (n=366)

Graph showing that 33.1% of patients with chronic migraine who received VYEPTI 300 mg experienced at least 75% fewer migraine days during weeks 1-12 vs 15.0% with placebo, and 43.1% of patients on VYEPTI 300 mg experienced at least 75% fewer migraine days during weeks 13-24 vs 23.8% with placebo. Callout text: 75% fewer migraine days with dose 1 and 2 of VYEPTI 300 mg.

≥75% migraine responder rate5*

 

VYEPTI 300 mg (n=350)

 

Placebo (n=366)

43.1% of patients treated with VYEPTI 300 mg experienced, on average, ≥75% fewer migraine days with dose 2.5

*75% responder rate was defined as a subject achieving, on average, a ≥75% reduction from baseline in migraine days within each 12-week interval.

†Key secondary endpoint (p<0.001).

‡Other secondary endpoint, not adjusted for multiplicity.

≥75% migraine responder rate5*

 

VYEPTI 100 mg (n=356)

 

Placebo (n=366)

Graph showing that 26.7% of patients with chronic migraine who received VYEPTI 100 mg experienced at least 75% fewer migraine days during weeks 1-12 vs 15.0% with placebo, and 39.3% of patients on VYEPTI 100 mg experienced at least 75% fewer migraine days during weeks 13-24 vs 23.8% with placebo.

≥75% migraine responder rate5*

 

VYEPTI 100 mg (n=356)

 

Placebo (n=366)

39.3% of patients treated with VYEPTI 100 mg experienced, on average, ≥75% fewer migraine days with dose 2.5

*75% responder rate was defined as a subject achieving, on average, a ≥75% reduction from baseline in migraine days within each 12-week interval.

†Key secondary endpoint (p<0.001).

‡Other secondary endpoint, not adjusted for multiplicity.

Patients had ≥15 to ≤26 headache days per month, of which ≥8 were migraine days.2

PROMISE-2 trial design graphic, showing screening for 28 days beginning at Week -4 and randomization into placebo (n=366), VYEPTI 100 mg (n=356), and VYEPTI 300 mg (n=350). IV treatments occurred at Week 0 and Week 12. The primary endpoint was measured at Week 12, and the study ended at Week 32.
PROMISE-22,3

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 1,072 patients were randomized and received placebo, VYEPTI 100 mg, or VYEPTI 300 mg every 12 weeks for 24 weeks
  • The study included patients with chronic migraine, some of whom had a dual diagnosis of medication overuse headache attributable to acute medication overuse
  • Primary endpoint: change from baseline in mean monthly migraine days over weeks 1-12

PROMISE, PRevention Of Migraine via Intravenous Eptinezumab Safety and Efficacy.

The study included:

  • Patients using an established stable regimen of acute migraine or headache prevention medication (except onabotulinumtoxinA)
  • Patients with a dual diagnosis of chronic migraine and medication overuse headache attributable to acute medication overuse (triptans, ergotamine, or combination analgesics >10 days per month)

The study excluded:

  • Patients using opioids or butalbital-containing products >4 days per month
  • Patients with a history of:
    • Cardiovascular disease (hypertension, ischemic heart disease)
    • Neurological disease
    • Cerebrovascular disease

≥75% migraine response rate6*

 

VYEPTI 300 mg (n=222)

 

Placebo (n=222)

Graph showing that 29.7% of patients with episodic migraine who received VYEPTI 300 mg experienced at least 75% fewer migraine days during weeks 1-12 vs 16.2% with placebo, and 40.1% of patients on VYEPTI experienced at least 75% fewer migraine days during weeks 13-24 vs 24.8% with placebo. Callout text: 75% fewer migraine days with dose 1 and 2 of VYEPTI 300 mg*

≥75% migraine response rate6*

 

VYEPTI 300 mg (n=222)

 

Placebo (n=222)

40.1% of patients treated with VYEPTI 300 mg experienced, on average, ≥75% fewer migraine days with dose 2.6

*75% responder rate was defined as a subject achieving, on average, a ≥75% reduction from baseline in migraine days within each 12-week interval.

†Key secondary endpoint (p<0.001).

‡Other secondary endpoint, not adjusted for multiplicity.

≥75% migraine response rate6*

 

VYEPTI 100 mg (n=221)

 

Placebo (n=222)

Graph showing that 22.2% of patients with episodic migraine who received VYEPTI 100 mg experienced at least 75% fewer migraine days during weeks 1-12 vs 16.2% with placebo, and 33.5% of patients on VYEPTI experienced at least 75% fewer migraine days during weeks 13-24 vs 24.8% with placebo.

≥75% migraine response rate6*

 

VYEPTI 100 mg (n=221)

 

Placebo (n=222)

33.5% of patients treated with VYEPTI 100 mg experienced, on average, ≥75% fewer migraine days with dose 2.6

*75% responder rate was defined as a subject achieving, on average, a ≥75% reduction from baseline in migraine days within each 12-week interval.

†Not statistically significant.

‡Other secondary endpoint, not adjusted for multiplicity.

Patients had 4 to 14 headache days per month, of which ≥4 were migraine days.2

PROMISE-1 trial design graphic showing screening for 28 days beginning at Week –4 and randomization into placebo (n=222), VYEPTI 100 mg (n=221), and VYEPTI 300 mg (n=222). IV treatments occurred at Week 0, Week 12, Week 24, and Week 36. The primary endpoint was measured at Week 12, and the study ended at Week 56
PROMISE-12,4

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, VYEPTI 100 mg, or VYEPTI 300 mg every 12 weeks for 56 weeks
  • The study also included a VYEPTI 30 mg (n=223) treatment arm, but is not an approved dose. VYEPTI 100 mg is the recommended dose. Some patients may benefit from the approved 300 mg dose
  • Primary endpoint: change from baseline in mean monthly migraine days over weeks 1-12

PROMISE, PRevention Of Migraine via Intravenous Eptinezumab Safety and Efficacy.

The study included:

  • Patients using concurrent acute migraine or headache medications, including migraine-specific medications (eg, triptans, ergotamine derivatives)

The study excluded patients with a history of:

  • Cardiovascular disease (hypertension, ischemic heart disease)
  • Neurological disease
  • Cerebrovascular disease

Fast onset: Day 1 post infusion results3†

 

VYEPTI 300 mg (n=350)

 

Placebo (n=366)

Graph showing that the number of patients experiencing a migraine was cut in half on Day 1 post infusion for patients treated with VYEPTI 300 mg (51.3%) vs with placebo (27.1%). Callout text: Post VYEPTI infusion, the percentage of patients experiencing a migraine was cut in half.

Fast onset: Day 1 post infusion results3†

 

VYEPTI 300 mg (n=350)

 

Placebo (n=366)

†Incidence on Day 1 was reduced by 51.6% with 300 mg vs 27.1% with placebo, p<0.0001 for each dose. Over the 28-day screening period, the average percentage of patients with a migraine any given day was ~58%.

Sustained prevention: Mean weekly migraine days through week 127,8

 

VYEPTI 300 mg (n=350)

 

Placebo (n=366)

Graph showing that patients with chronic migraine who received both VYEPTI 300 mg and the placebo experienced a mean weekly reduction in migraine days for weeks 1-12. Results show that at a population level, no observation of wearing off between infusions occurred. Callout text: Over the first 12 weeks, there was no observation of wearing off with VYEPTI 300 mg.

Sustained prevention: Mean weekly migraine days through week 127,8

 

VYEPTI 300 mg (n=350)

 

Placebo (n=366)

Post hoc analysis: Over the first 12 weeks, mean weekly migraine days showed that the migraine frequency was lower with VYEPTI 300 mg vs placebo at all time points. At a population level, no observation of wearing off occurred.

Fast onset: Day 1 post infusion results3†

 

VYEPTI 100 mg (n=356)

 

Placebo (n=366)

Graph showing that the number of patients experiencing a migraine was cut in half on Day 1 post infusion for patients treated with VYEPTI 100 mg (50.3%) vs with placebo (27.1%). Callout text: Post VYEPTI infusion, the percentage of patients experiencing a migraine was cut in half.

Fast onset: Day 1 post infusion results3†

 

VYEPTI 100 mg (n=356)

 

Placebo (n=366)

†Incidence on Day 1 was reduced by 50.3% with 100 mg vs 27.1% with placebo, p<0.0001 for each dose. Over the 28-day screening period, the average percentage of patients with a migraine any given day was ~58%.

Sustained prevention: Mean weekly migraine days through week 127,8

 

VYEPTI 100 mg (n=356)

 

Placebo (n=366)

Graph showing that patients with chronic migraine who received both VYEPTI 100 mg and the placebo experienced a mean weekly reduction in migraine days for weeks 1-12. Results show that at a population level, no observation of wearing off between infusions occurred.

Sustained prevention: Mean weekly migraine days through week 127,8

 

VYEPTI 100 mg (n=356)

 

Placebo (n=366)

Post hoc analysis: Over the first 12 weeks, mean weekly migraine days showed that the migraine frequency was lower with VYEPTI 100 mg vs placebo at all time points. At a population level, no observation of wearing off occurred.

Patients had ≥15 to ≤26 headache days per month, of which ≥8 were migraine days.2

PROMISE-2 trial design graphic, showing screening for 28 days beginning at Week -4 and randomization into placebo (n=366), VYEPTI 100 mg (n=356), and VYEPTI 300 mg (n=350). IV treatments occurred at Week 0 and Week 12. The primary endpoint was measured at Week 12, and the study ended at Week 32.
PROMISE-22,3

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 1,072 patients were randomized and received placebo, VYEPTI 100 mg, or VYEPTI 300 mg every 12 weeks for 24 weeks
  • The study included patients with chronic migraine, some of whom had a dual diagnosis of medication overuse headache attributable to acute medication overuse
  • Primary endpoint: change from baseline in mean monthly migraine days over weeks 1-12

PROMISE, PRevention Of Migraine via Intravenous Eptinezumab Safety and Efficacy.

The study included:

  • Patients using an established stable regimen of acute migraine or headache prevention medication (except onabotulinumtoxinA)
  • Patients with a dual diagnosis of chronic migraine and medication overuse headache attributable to acute medication overuse (triptans, ergotamine, or combination analgesics >10 days per month)

The study excluded:

  • Patients using opioids or butalbital-containing products >4 days per month
  • Patients with a history of:
    • Cardiovascular disease (hypertension, ischemic heart disease)
    • Neurological disease
    • Cerebrovascular disease

Reduction in mean acute headache medication (AHM) days over two doses5,9*

 

VYEPTI 300 mg (n=350)

 

Placebo (n=366)

Graph showing a ≥52% reduction in mean acute headache medication (AHM) use in patients with chronic migraine who received VYEPTI 300 mg (n=350) vs 35% with placebo (n=366). Callout text: ≥52% decrease in AHM days with VYEPTI 300 mg vs 35% with placebo.

Reduction in mean acute headache medication (AHM) days over two doses5,9*

 

VYEPTI 300 mg (n=350)

 

Placebo (n=366)

*AHM use was a prespecified endpoint for the 300 mg dose in weeks 1-12. All other results were exploratory analyses and not adjusted for multiplicity. An AHM day was a day with any triptan or ergotamine use as recorded in the eDiary. If a patient used multiple medications on the same day, they were counted once.

Reduction in mean acute headache medication (AHM) days over two doses5,9*

 

VYEPTI 100 mg (n=356)

 

Placebo (n=366)

Graph showing an ~47% reduction in mean acute headache medication use in patients with chronic migraine who received VYEPTI 100 mg (n=356) vs 35% with placebo (n=366).

Reduction in mean acute headache medication (AHM) days over two doses5,9*

 

VYEPTI 100 mg (n=356)

 

Placebo (n=366)

*Results were exploratory and not adjusted for multiplicity. An AHM day was a day with any triptan or ergotamine use as recorded in the eDiary. If a patient used multiple medications on the same day, they were counted once.

Patients had ≥15 to ≤26 headache days per month, of which ≥8 were migraine days.2

PROMISE-2 trial design graphic, showing screening for 28 days beginning at Week -4 and randomization into placebo (n=366), VYEPTI 100 mg (n=356), and VYEPTI 300 mg (n=350). IV treatments occurred at Week 0 and Week 12. The primary endpoint was measured at Week 12, and the study ended at Week 32.
PROMISE-22,3

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 1,072 patients were randomized and received placebo, VYEPTI 100 mg, or VYEPTI 300 mg every 12 weeks for 24 weeks
  • The study included patients with chronic migraine, some of whom had a dual diagnosis of medication overuse headache attributable to acute medication overuse
  • Primary endpoint: change from baseline in mean monthly migraine days over weeks 1-12

PROMISE, PRevention Of Migraine via Intravenous Eptinezumab Safety and Efficacy.

The study included:

  • Patients using an established stable regimen of acute migraine or headache prevention medication (except onabotulinumtoxinA)
  • Patients with a dual diagnosis of chronic migraine and medication overuse headache attributable to acute medication overuse (triptans, ergotamine, or combination analgesics >10 days per month)

The study excluded:

  • Patients using opioids or butalbital-containing products >4 days per month
  • Patients with a history of:
    • Cardiovascular disease (hypertension, ischemic heart disease)
    • Neurological disease
    • Cerebrovascular disease

Percentage of patients experiencing severe life impact as measured by HIT-65,9*†

 

VYEPTI 300 mg (n=350)

 

Placebo (n=366)

Chart showing that the percentage of patients experiencing severe life impact was cut in half with VYEPTI 300 mg compared to placebo.

Percentage of patients experiencing severe life impact as measured by HIT-65,9*†

 

VYEPTI 300 mg (n=350)

 

Placebo (n=366)

At baseline, based on HIT-6 total scores, 88.6% (VYEPTI 300 mg) and 87.4% (placebo) of patients had severe headache-related life impact (i.e., a score of ≥60). The percentage of patients with a severe life impact dropped to 39.7% with VYEPTI 300 mg compared to 55.3% in the placebo group at week 24.5

*HIT-6 has been validated in patients with chronic migraine and was administered at screening, day 0, and each study visit through week 32. Patients rated the impact of headaches on their ability to function normally in daily life as: never, rarely, sometimes, very often, and always. Scores ≥60 were indicative of severe life impact, 56 to 59 of substantial life impact, 50 to 55 of some life impact, and ≤49 of little to no life impact.

†Key secondary endpoint.

Percentage of patients experiencing severe life impact as measured by HIT-65,9*†

 

VYEPTI 300 mg (n=356)

 

Placebo (n=366)

Chart showing that the percentage of patients experiencing severe life impact was cut in half with VYEPTI 100 mg compared to placebo.

Percentage of patients experiencing severe life impact as measured by HIT-65,9*†

 

VYEPTI 300 mg (n=356)

 

Placebo (n=366)

At baseline, based on HIT-6 total scores, 89.6% (VYEPTI 100 mg) and 87.4% (placebo) of patients had severe headache-related life impact (i.e., a score of ≥60). The percentage of patients with a severe life impact dropped to 43.5% with VYEPTI 100 mg compared to 55.3% in the placebo group at week 24.5

*HIT-6 has been validated in patients with chronic migraine and was administered at screening, day 0, and each study visit through week 32. Patients rated the impact of headaches on their ability to function normally in daily life as: never, rarely, sometimes, very often, and always. Scores ≥60 were indicative of severe life impact, 56 to 59 of substantial life impact, 50 to 55 of some life impact, and ≤49 of little to no life impact.

†Other secondary endpoint.

Patients had ≥15 to ≤26 headache days per month, of which ≥8 were migraine days.2

PROMISE-2 trial design graphic, showing screening for 28 days beginning at Week -4 and randomization into placebo (n=366), VYEPTI 100 mg (n=356), and VYEPTI 300 mg (n=350). IV treatments occurred at Week 0 and Week 12. The primary endpoint was measured at Week 12, and the study ended at Week 32.
PROMISE-22,3

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 1,072 patients were randomized and received placebo, VYEPTI 100 mg, or VYEPTI 300 mg every 12 weeks for 24 weeks
  • The study included patients with chronic migraine, some of whom had a dual diagnosis of medication overuse headache attributable to acute medication overuse
  • Primary endpoint: change from baseline in mean monthly migraine days over weeks 1-12

PROMISE, PRevention Of Migraine via Intravenous Eptinezumab Safety and Efficacy.

The study included:

  • Patients using an established stable regimen of acute migraine or headache prevention medication (except onabotulinumtoxinA)
  • Patients with a dual diagnosis of chronic migraine and medication overuse headache attributable to acute medication overuse (triptans, ergotamine, or combination analgesics >10 days per month)

The study excluded:

  • Patients using opioids or butalbital-containing products >4 days per month
  • Patients with a history of:
    • Cardiovascular disease (hypertension, ischemic heart disease)
    • Neurological disease
    • Cerebrovascular disease
2-year data icon

PREVAIL: A 2-year, single-arm, open-label, phase 3 trial to evaluate the long-term safety and tolerability of VYEPTI for the preventive treatment of chronic migraine in adults.10,11

Reduce the impact of migraine for your patients

High treatment persistency was demonstrated over 2 years††

††In the 2-year PREVAIL study, a total of 118 patients (92.2%) completed the primary treatment phase (week 48), and 101 (78.9%) completed the secondary (week 84); 100 patients (78.1%) remained on VYEPTI 20 weeks after administration of the final study dose (week 104), and 6.3% discontinued study drug due to adverse events.

~80%

of patients treated with VYEPTI 300 mg continued to receive treatment10,11

††In the 2-year PREVAIL study, a total of 118 patients (92.2%) completed the primary treatment phase (week 48), and 101 (78.9%) completed the secondary (week 84); 100 patients (78.1%) remained on VYEPTI 20 weeks after administration of the final study dose (week 104), and 6.3% discontinued study drug due to adverse events.

Teal gradient background

Read full 2-year study publicationLink out icon Read full 2-year study post hoc analysisLink out icon
PREVAIL trial design graphic showing screening for 14 days beginning at Week -2. Patients received infusions on VYEPTI 300 mg every 12 weeks, beginning with the first dose at week 0, for as long as they continued with the study. PREVAIL consisted of two treatment periods and one follow-up. The primary treatment period followed patients from week 0 (N=128) through week 48 (n=118). The secondary treatment period ran from week 48 through week 84 (n=101). Patients were followed for 20 weeks after their final infusion. The study concluded at week 104 (n=100).

PREVAIL10,11

A 2-year, single-arm, open-label, phase 3 trial to evaluate the long-term safety and tolerability of VYEPTI for the preventive treatment of chronic migraine in adults.

  • Adults with chronic migraine received VYEPTI 300 mg every 12 weeks for up to 8 doses. Patients who received the first 4 doses (112/128 [87.5%]) could continue to receive the remaining 4 doses. Patients were followed for 20 weeks after final infusion (end-of-study visit at week 104)
  • Endpoints assessed safety as well as patient-reported outcomes

Data from open-label studies have limitations, as the study was not blinded or placebo controlled. The study only assessed patients on the 300 mg dose.

The study included:

  • Adults (18-65 years old) with an ICHD-3β diagnosis of migraine at or before age 50 with ≥12-month history of chronic migraine advised by a healthcare professional to use medication to treat their migraine
    • Prior migraine prophylactic medications had to be stable for 3 months prior
    • Limited use of barbiturate or prescription opiates was allowed

The study excluded patients who:

  • Required botulinum toxin injections for any reason within 4 months prior to screening
  • Received any monoclonal antibody targeting the CGRP pathway within 6 months prior to screening
  • Had pre-existing significant cardiovascular disease
  • Had clinically significant pain syndromes

ICHD, International Classification of Headache Disorders.

Image of VYEPTI packaging and vial

VYEPTI 100 mg is the recommended dose. Some patients may benefit from the approved 300 mg dose.

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.

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.

Hypertension: Development of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists, including VYEPTI, in the postmarketing setting. Some of the patients who developed new-onset hypertension had risk factors for hypertension. There were cases requiring initiation of pharmacological treatment for hypertension, and in some cases hospitalization. Hypertension may occur at any time during treatment, but was most frequently reported within 7 days of therapy initiation. The CGRP antagonist was discontinued in many of the reported cases.

Monitor patients treated with VYEPTI for new-onset hypertension or worsening of pre-existing hypertension, and consider whether discontinuation of VYEPTI is warranted if evaluation fails to establish an alternative etiology or blood pressure is inadequately controlled.

Raynaud’s Phenomenon: Development of Raynaud’s phenomenon and recurrence or worsening of pre-existing Raynaud’s phenomenon have been reported in the postmarketing setting following the use of CGRP antagonists. In reported cases with monoclonal antibody CGRP antagonists, symptom onset occurred a median of 71 days following dosing. Many of the cases reported serious outcomes, including hospitalizations and disability, generally related to debilitating pain. In most reported cases, discontinuation of the CGRP antagonist resulted in resolution of symptoms.

VYEPTI should be discontinued if signs or symptoms of Raynaud’s phenomenon develop, and patients should be evaluated by a healthcare provider if symptoms do not resolve. Patients with a history of Raynaud’s phenomenon should be monitored for, and informed about the possibility of, worsening or recurrence of signs and symptoms.

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.

INDICATION

VYEPTI is indicated for the preventive treatment of migraine in adults.

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.

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.

Hypertension: Development of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists, including VYEPTI, in the postmarketing setting. Some of the patients who developed new-onset hypertension had risk factors for hypertension. There were cases requiring initiation of pharmacological treatment for hypertension, and in some cases hospitalization. Hypertension may occur at any time during treatment, but was most frequently reported within 7 days of therapy initiation. The CGRP antagonist was discontinued in many of the reported cases.

Monitor patients treated with VYEPTI for new-onset hypertension or worsening of pre-existing hypertension, and consider whether discontinuation of VYEPTI is warranted if evaluation fails to establish an alternative etiology or blood pressure is inadequately controlled.

Raynaud’s Phenomenon: Development of Raynaud’s phenomenon and recurrence or worsening of pre-existing Raynaud’s phenomenon have been reported in the postmarketing setting following the use of CGRP antagonists. In reported cases with monoclonal antibody CGRP antagonists, symptom onset occurred a median of 71 days following dosing. Many of the cases reported serious outcomes, including hospitalizations and disability, generally related to debilitating pain. In most reported cases, discontinuation of the CGRP antagonist resulted in resolution of symptoms.

VYEPTI should be discontinued if signs or symptoms of Raynaud’s phenomenon develop, and patients should be evaluated by a healthcare provider if symptoms do not resolve. Patients with a history of Raynaud’s phenomenon should be monitored for, and informed about the possibility of, worsening or recurrence of signs and symptoms.

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.

INDICATION

VYEPTI is indicated for the preventive treatment of migraine in adults.

For more information, please see the Full Prescribing Information and Patient Information.

References:

  1. 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.
  2. VYEPTI (eptinezumab-jjmr) [package insert]. Bothell, WA: Lundbeck Seattle BioPharmaceuticals, Inc.
  3. 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.
  4. 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.
  5. Silberstein 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):120-132.
  6. Smith TR, Janelidze M, Chakhava G, et al. Eptinezumab for the prevention of episodic migraine: sustained effect through 1 year of treatment in the PROMISE-1 study. Clin Ther. 2020;42(12):2254-2265.e3.
  7. Dodick DW, Gottschalk C, Cady R, Hirman J, Smith J, Snapinn S. Eptinezumab demonstrated efficacy in sustained prevention of episodic and chronic migraine beginning on day 1 after dosing. Headache. 2020;60(10):2220-2231.
  8. Cady R, Asher D, Soni-Brahmbhatt S, et al. No "wearing off" effect observed with eptinezumab in the preventive treatment of migraine. Poster presented at: 75th Annual Meeting of the American Academy of Neurology (AAN): Apr 22-27, 2023; Boston, MA and virtual. P13.009.
  9. Data on file. Bothell, WA: Lundbeck Seattle BioPharmaceuticals, Inc.
  10. Blumenfeld A, Ettrup A, Hirman J, et al. Long-term reductions in disease impact in patients with chronic migraine following preventive treatment with eptinezumab. BMC Neurology. 2022;22(251):1-9.
  11. Kudrow D, Cady RK, Allan B, et al. Long-term safety and tolerability of eptinezumab in patients with chronic migraine: a 2-year, open-label, phase 3 trial. BMC Neurology. 2021;21(126):1-12.
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