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

VYEPTI pivotal trial data

CHRONIC MIGRAINE (PROMISE-2)

After a single dose, patients experienced fewer migraine days

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

 
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).1,2†

* 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.

Graph showing change from baseline in mean monthly migraine days over weeks 1-12 in patients with chronic migraine. Text in image states: "Patients experienced, on average, 24.6 & 23.1 fewer MMDs with 1 dose of VYEPTI(1,2*)"
Patients experienced,
on average, 24.6 &
23.1
FEWER
MMDs with 1 dose of
VYEPTI1,2*

Chronic migraineRead full clinical publication

Chart showing PROMISE-2 study design for chronic migraine.
PROMISE-21,2

A randomized, double-blind, placebo-controlled, parallel-group, Phase 3 trial evaluating the safety and efficacy of VYEPTI in adults with chronic migraine.

  • A total of 1072 patients were randomized and received placebo, VYEPTI 100 mg, or VYEPTI 300 mg every 12 weeks for 24 weeks
  • Participants had 15 to 26 headache days per month, of which ≥8 were migraine days
  • The study enrolled adults with chronic migraine; 40% 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)1,3

 
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).1,3§

*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.

Graph showing change from baseline in mean monthly migraine days over weeks 1-12 in patients with episodic migraine. Text in image states: "Patients experienced, on average, 12.9 & 11.7 fewer MMDs with 1 dose of VYEPTI(1,5‡)"
Patients experienced,
on average, 12.9 &
11.7
FEWER
MMDs with 1 dose of
VYEPTI1,3‡

Episodic migraineRead full clinical publication

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

Chart showing PROMISE-1 study design for episodic migraine.
PROMISE-11,5

A parallel-group, double-blind, placebo-controlled global trial to evaluate the efficacy and safety of VYEPTI in adults
with episodic migraine.

  • 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

CHRONIC MIGRAINE (PROMISE-2)

Fewer migraine days are possible

≥75% migraine responder rate4*

 
 
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 2.4

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

† Key secondary endpoint (p<0.001) vs placebo.

‡ Other secondary endpoint.

Graph showing ≥75% migraine responder rate in PROMISE-2 study with VYEPTI 300 mg. Text in image states: "75% fewer migraine days with dose 1 and 2 of VYEPTI 300 mg(3*)"
75%
FEWER
 migraine days with dose 1 and 2
of VYEPTI 300 mg4*

≥75% migraine responder rate4*

 
 
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 2.4

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

† Key secondary endpoint (p<0.001) vs placebo.

‡ Other secondary endpoint.

Graph showing ≥75% migraine responder rate in PROMISE-2 study with VYEPTI 100 mg. Text in image states: "75% fewer migraine days with dose 1 and 2 of VYEPTI 100 mg(3*)"
75%
FEWER
 migraine days with dose 1 and 2
of VYEPTI 100 mg4*

Chronic migraineRead full clinical publication

Chart showing PROMISE-2 study design for chronic migraine.
PROMISE-21,2

A randomized, double-blind, placebo-controlled, parallel-group, Phase 3 trial evaluating the safety and efficacy of VYEPTI in adults with chronic migraine.

  • A total of 1072 patients were randomized and received placebo, VYEPTI 100 mg, or VYEPTI 300 mg every 12 weeks for 24 weeks
  • Participants had 15 to 26 headache days per month, of which ≥8 were migraine days
  • The study enrolled adults with chronic migraine; 40% 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

300 mg data

≥75% migraine responder rate5*

 
 
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 2.5

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

† Key secondary endpoint (p<0.001) vs placebo.

‡ Other secondary endpoint.

Graph showing ≥75% migraine responder rate in PROMISE-1 study with VYEPTI 300 mg. Text in image states: "75% fewer migraine days with dose 1 and 2 of VYEPTI 300 mg(6*)"
75%
FEWER
 migraine days with dose 1 and 2
of VYEPTI 300 mg5*

≥75% migraine responder rate5*

 
 
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 2.5

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

† Not statistically significant.

‡ Other secondary endpoint.

Graph showing ≥75% migraine responder rate in PROMISE-1 study with VYEPTI 100 mg. Text in image states: "75% fewer migraine days with dose 1 and 2 of VYEPTI 100 mg(6*)"
75%
FEWER
 migraine days with dose 1 and 2
of VYEPTI 100 mg5*

Episodic migraineRead full clinical publication

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

Chart showing PROMISE-1 study design for episodic migraine.
PROMISE-11,5

A parallel-group, double-blind, placebo-controlled global trial to evaluate the efficacy and safety of VYEPTI in adults
with episodic migraine.

  • 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

CHRONIC MIGRAINE (PROMISE-2)

Early benefit seen within the first
7 days and as soon as Day 1 post infusion, in an FDA-approved label analysis1

Data represent mean percent of patients based on observed data. During the first seven days of treatment, more patients on VYEPTI had migraine-free days than those on placebo, with a migraine from Day -1 (prior to infusion) to Day 7.

Fast onset: Day 1 post infusion results2*

 
 
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%.

Graph showing Day 1 and weeks 1-4 post infusion results from the PROMISE-2 study with VYEPTI 300 mg. Text in image states: "Post VYEPTI infusion, the percentage of patients experiencing a migraine was cut in half with VYEPTI 300 mg(2)"
Post VYEPTI infusion,
the percentage of patients experiencing a MIGRAINE WAS CUT IN HALF
with VYEPTI 300 mg2

Mean weekly migraine days through week 126,7

 
 
VYEPTI 300 mg
(n=350)
 
Placebo
(n=366)
 
Post hoc analysis is exploratory and hypothesis-generating. Due to the lack of randomization or control group or control for type 1 error rate, it is not possible to determine if the observed effect is attributable to VYEPTI or to other factors.

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.

Graph showing sustained prevention in mean weekly migraine days through week 12 in the PROMISE-2 study with VYEPTI 300 mg.

Fast onset: Day 1 post infusion results2*

 
 
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%.

Graph showing Day 1 and weeks 1-4 post infusion results from the PROMISE-2 study with VYEPTI 100 mg. Text in image states: "Post VYEPTI infusion, the percentage of patients experiencing a migraine was cut in half with VYEPTI 100 mg(2)"
Post VYEPTI infusion,
the percentage of patients experiencing a MIGRAINE WAS CUT IN HALF
with VYEPTI 100 mg2

Mean weekly migraine days through week 126,7

 
 
VYEPTI 100 mg
(n=356)
 
Placebo
(n=366)
 
Post hoc analysis is exploratory and hypothesis-generating. Due to the lack of randomization or control group or control for type 1 error rate, it is not possible to determine if the observed effect is attributable to VYEPTI or to other factors.

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.

Graph showing sustained prevention in mean weekly migraine days through week 12 in the PROMISE-2 study with VYEPTI 100 mg.

Chronic migraineRead full clinical publication

Chart showing PROMISE-2 study design for chronic migraine.
PROMISE-21,2

A randomized, double-blind, placebo-controlled, parallel-group, Phase 3 trial evaluating the safety and efficacy of VYEPTI in adults with chronic migraine.

  • A total of 1072 patients were randomized and received placebo, VYEPTI 100 mg, or VYEPTI 300 mg every 12 weeks for 24 weeks
  • Participants had 15 to 26 headache days per month, of which ≥8 were migraine days
  • The study enrolled adults with chronic migraine; 40% 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

CHRONIC MIGRAINE (PROMISE-2)

Reduction in mean acute headache medication (AHM) days over two doses3,8*

 
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.

Graph showing reduction in mean acute headache medication (AHM) days over two doses in the PROMISE-2 study with VYEPTI 300 mg. Text in image states: "≥52% decrease in mean AHM days with VYEPTI 300 mg vs 35% with placebo(3,4*)"
≥52%
DECREASE
 in mean AHM days
with VYEPTI 300 mg vs 35% with placebo3,8*

Reduction in mean acute headache medication (AHM) days over two doses3,8*

 
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.

Graph showing reduction in mean acute headache medication (AHM) days over two doses in the PROMISE-2 study with VYEPTI 100 mg. Text in image states: "≥52% decrease in mean AHM days with VYEPTI 100 mg vs 35% with placebo(3,4*)"
≥52%
DECREASE
 in mean AHM days
with VYEPTI 100 mg vs 35% with placebo3,8*

Chronic migraineRead full clinical publication

Chart showing PROMISE-2 study design for chronic migraine.
PROMISE-21,2

A randomized, double-blind, placebo-controlled, parallel-group, Phase 3 trial evaluating the safety and efficacy of VYEPTI in adults with chronic migraine.

  • A total of 1072 patients were randomized and received placebo, VYEPTI 100 mg, or VYEPTI 300 mg every 12 weeks for 24 weeks
  • Participants had 15 to 26 headache days per month, of which ≥8 were migraine days
  • The study enrolled adults with chronic migraine; 40% 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
Brad Klein, MD, MBA, smiling.

“Patients want fewer migraine days so that they can focus on what is truly important in their lives: their friends, their family, and their career.”

Brad Klein, MD, MBA**

Medical Director, Headache Specialist | Abington Headache Center, Abington Neurological Associates, Ltd. | 
Abington, PA

VYEPTI packaging and vial.

VYEPTI 100 mg is the recommended dose. Some patients may benefit from the approved 300 mg dose.1

** Healthcare professionals on this page are paid consultants of Lundbeck.

""
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.

Constipation with Serious Complications: Constipation with serious complications has been reported following the use of monoclonal antibody CGRP antagonists, including VYEPTI, in the postmarketing setting. There were cases with monoclonal antibody CGRP antagonists that required hospitalization, including cases where surgery was necessary. In a majority of these cases, the onset of constipation was reported after the first dose; however, patients have also presented with constipation later on in treatment. The monoclonal antibody CGRP antagonist was discontinued in many of the reported cases of constipation with serious complications.

Monitor patients treated with VYEPTI for severe constipation and manage as clinically appropriate. The concurrent use of medications that reduce gastrointestinal motility may increase the risk for more severe constipation and the potential for constipation-related complications.

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.

Constipation with Serious Complications: Constipation with serious complications has been reported following the use of monoclonal antibody CGRP antagonists, including VYEPTI, in the postmarketing setting. There were cases with monoclonal antibody CGRP antagonists that required hospitalization, including cases where surgery was necessary. In a majority of these cases, the onset of constipation was reported after the first dose; however, patients have also presented with constipation later on in treatment. The monoclonal antibody CGRP antagonist was discontinued in many of the reported cases of constipation with serious complications.

Monitor patients treated with VYEPTI for severe constipation and manage as clinically appropriate. The concurrent use of medications that reduce gastrointestinal motility may increase the risk for more severe constipation and the potential for constipation-related complications.

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. VYEPTI (eptinezumab-jjmr) [package insert]. Bothell, WA: Lundbeck Seattle BioPharmaceuticals, Inc.
  2. 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.
  3. Ashina M, Saper J, Cady R, 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.
  4. 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.
  5. 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.
  6. 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.
  7. Cady R, Asher D, Soni-Brahmbhatt S, Hirman J, Dodick DW. 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): April 22-27, 2023; Boston, MA, and virtual. P13.009.
  8. Data on file. Bothell, WA: Lundbeck Seattle BioPharmaceuticals, Inc.