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Indication   Aimovig® (erenumab-aooe) is indicated for the preventive treatment of migraine in adults.

INDICATION

PRESCRIBING INFORMATION

RESOURCES

For US Healthcare Professionals Only
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IMPORTANT SAFETY INFORMATION
VISIT PATIENT SITE
  • EPISODIC MIGRAINE
  • CHRONIC MIGRAINE
  • MMDs
  • RESPONSE RATES
  • Months 4-6 & Year 1
  • Year 5
MONTHS 4-6

In a phase 3 EM study

Patients experience more migraine-free days with Aimovig®, starting at Month 11,2

Change from baseline chart in mean MMDs over months 4 to 6
Change from baseline chart in mean MMDs over months 4 to 6
Patients with ~8 MMDs at baseline experienced up to 3.7 MORE MIGRAINE-FREE DAYS over Months 4 to 61

This was a phase 3, randomized double-blind, placebo-controlled study of adult episodic migraine patients.1

Study Information

Aimovig® was evaluated for the prevention of episodic migraine in patients aged 18 to 65 years with 4 to 14 monthly migraine days (MMDs) in this multicenter, 24-week study.1

*Earliest post-baseline prespecified assessment.1

†Least-square means are presented. For Aimovig® 70 mg, the difference from placebo was -1.4 (95% CI: -1.9, -0.9). For Aimovig® 140 mg, the difference from placebo was -1.9 (95% CI: -2.3, -1.4).1,2

EM=episodic migraine; MMDs=monthly migraine days.

Year 1

In the phase 3 EM active treatment phase

Efficacy was maintained at 1 year of treatment3

Fewer migraine days of Aimovig® 70 mg | Fewer migraine days of Aimovig® 140 mg
Fewer migraine days of Aimovig® 70 mg | Fewer migraine days of Aimovig® 140 mg
Study Information

ATP=active treatment phase; DBTP=double-blind treatment phase.

Year 5

In a phase 2 EM study

Aimovig® demonstrated sustained efficacy with results out to 5 years

Change from baseline chart in mean MDDs at month 3 and year 5 for episodic migraines
Change from baseline chart in mean MDDs at month 3 and year 5 for episodic migraines

Consider open-label treatment phase study limitations when interpreting results. The OLTP was not blinded, not controlled, and included inherent self-selection bias for remaining in the trial. Overall, a total of 167 patients (43.6%) discontinued during the study, of which 18 patients (4.7%) discontinued due to adverse events.1

*Study included additional dosage arms, which were not included in the FDA-approved labeling.

Study Information

Aimovig® was evaluated in a phase 2, multicenter, randomized, placebo-controlled, double-blind, dose-finding study of subjects with episodic migraine. The primary outcome measure was the change in mean MMDs at Month 3. The mean migraine frequency at baseline was ~9 MMDs across treatment groups (placebo, n=160; 70 mg, n=107). Following the 12-week DBTP, subjects were able to continue in a 5-year OLTP of Aimovig® (N=383).1,3

The OLTP evaluated the long-term efficacy, safety, and tolerability of Aimovig® at 5 years of exposure. A protocol amendment increased the dosage to 140 mg in all subjects after a median of 2.0 years of exposure to 70 mg monthly in the OLTP. As a post hoc analysis, efficacy was evaluated in these subjects based on last dose received.1,3

DBTP=double-blind treatment phase; MMDs=monthly migraine days; OLTP=open-label treatment phase.

DBTP=double-blind treatment phase; MMDs=monthly migraine days; OLTP=open-label treatment phase.

  • ≥50% Response
  • ≥75% Response
Months 4-6

In a phase 3 EM study

Up to half of Aimovig®-treated patients cut migraine days by at least 50%

Percentage of patients who achieved at least a 50% reduction from baseline in MMDs
Percentage of patients who achieved at least a 50% reduction from baseline in MMDs
  • ≥50% response rate was the secondary endpoint in the phase 3, double-blind, randomized study1,2

*Odds of achieving a ≥50% reduction were significantly higher (2.1x, 95% CI: 1.5, 3.0) for the Aimovig® 70 mg group than for the placebo group (P<0.001).1,2

†Odds of achieving a ≥50% reduction were significantly higher (2.8x, 95% CI: 2.0, 3.9) for the Aimovig® 140 mg group than for the placebo group (P<0.001).1,2

Year 5

In a phase 2 EM study

~7 out of 10 Aimovig®-treated patients cut migraine days by at least 50%

71% of patients receiving Aimovig® 140 mg achieved a 50% reduction in monthly migraine days
71% of patients receiving Aimovig® 140 mg achieved a 50% reduction in monthly migraine days
  • 46% of Aimovig® 70 mg patients achieved a ≥50% reduction in MMDs at the 3-month DBTP portion of this phase 2 EM study vs 30% for placebo4

Consider open-label treatment phase study limitations when interpreting results. The OLTP was not blinded, not controlled, and included inherent self-selection bias for remaining in the trial. Overall, a total of 167 patients (43.6%) discontinued during the study, of which 18 patients (4.7%) discontinued due to adverse events.5

MMDs
≥75% RESPONSE
DBTP=double-blind treatment phase; EM=episodic migraine; MMDs=monthly migraine days; OLTP=open-label treatment phase.
Months 4-6

In a phase 3 EM study exploratory analysis

~1 in 5 Aimovig®-treated patients cut migraine days by at least 75%1

Percentage of patients who achieved at least a 75% reduction from baseline in MMDs
Percentage of patients who achieved at least a 75% reduction from baseline in MMDs
  • ≥75% response rate is an exploratory analysis and has not been adjusted for multiple comparisons. No conclusions of statistical or clinical significance can be drawn1
Year 5

In a phase 2 EM study

~5 out of 10 Aimovig®-treated patients cut migraine days by at least 75%3,4,*

47% of patients receiving Aimovig® 140 mg achieved a 75% reduction in monthly migraine days
47% of patients receiving Aimovig® 140 mg achieved a 75% reduction in monthly migraine days
  • 20.7% of Aimovig® 70 mg patients achieved a ≥75% reduction in MMDs at the 3-month DBTP portion of this phase 2 EM study vs 13.3% for placebo3,4,*

Consider open-label treatment phase study limitations when interpreting results. The OLTP was not blinded, not controlled, and included inherent self-selection bias for remaining in the trial. Overall, a total of 167 patients (43.6%) discontinued during the study, of which 18 patients (4.7%) discontinued due to adverse events.5

*Represents only patients who entered into open-label treatment phase.4

≥50% RESPONSE
CHRONIC MIGRAINE

DBTP=double-blind treatment phase; EM=episodic migraine; MMDs=monthly migraine days; OLTP=open-label treatment phase.

  • MMDs
  • PRIOR PREVENTIVES
MONTH 3 & MONTH 16

In a phase 2 CM study

With Aimovig®, patients with chronic migraine can have fewer monthly migraine days*

Change in mean MMDs between baseline at month 3 and at month 16
Change in mean MMDs between baseline at month 3 and at month 16

Consider open-label treatment phase study limitations when interpreting results. The OLTP was not blinded, not controlled, and included inherent self-selection bias. Overall, 22.8% (n=139) patients discontinued Aimovig® during the study, of which 2.6% (n=16) patients discontinued due to AEs.2

Study Information

*Versus placebo in the DBTP; vs baseline in OLTP.1,2

†Least-square means are presented. Statistically significant reductions in monthly migraine days at Month 3 for Aimovig® 70 mg and 140 mg vs placebo (P<0.001). For both Aimovig® 70 mg and Aimovig® 140 mg, the difference from placebo was -2.5% (95% CI: -3.5, -1.4).1,3

AE=adverse event; CM=chronic migraine; DBTP=double-blind treatment phase; EM=episodic migraine; MMDs=monthly migraine days; OLTP=open-label treatment phase; QM=once a month.

  • Medication overuse headache (MOH)

    Medication overuse (MOU) is the frequent use of acute treatments for an underlying headache disorder, such as chronic migraine. This overuse leads to the development of a secondary headache disorder known as medication overuse headache (MOH).4

    • MOH is characterized by increased or worsening headaches and has clinical features similar to the underlying primary headache disorder, making its diagnosis a challenge4

    Per the ICHD-3, the criteria for medication overuse headache (MOH) is:4,5

    15-days≥15 headache days per month
    3-months&gt;3 months of regular overuse of one or more drugs that can be taken for acute and/or symptomatic treatment of headache
    developDeveloped a new type of headache or a significant worsening of their pre-existing headache
    notNot better accounted for by another ICHD-3 diagnosis

    In a phase 4 CM with MOH study

    Aimovig® 140 mg was superior in achieving MOH remission in chronic migraine patients vs placebo5

    Aimovig® was studied in a phase 4, randomized, double-blind, parallel group, placebo-controlled study, evaluating efficacy and safety in adults with chronic migraine for at least 12 months who have a history of at least one preventive treatment failure and have been diagnosed with MOH. This analysis comprised 584 patients in a non-opioid-treated cohort who were randomized 1:1:1.5

    Primary endpoint5

    • Absence of MOH at Month 6 of the DBTP*

    Key secondary endpoints5

    • Change from baseline in mean monthly AHMDs over Months 4, 5, and 6 of the DBTP
    • Sustained MOH remission during DBTP, as defined by absence of MOH at Months 3 and 6 of the DBTP†

    *Defined by mean monthly treatment of AHMDs <10 days over Months 4, 5, and 6 and/or mean MHDs <14 days (in a 28-day study month) over Months 4, 5, and 6 of the DBTP, where AHMDs include any eDiary day in which an acute headache medication intake is reported.

    †“Absence of MOH” is achieved when mean monthly AHMDs <10 days and/or mean MHDs <14 days over the respective 3-month period.

    ‡Least-square means are presented. Statistically significant reductions in AHMDs for Aimovig® 140 mg vs placebo (difference from placebo -2.7 [95% Cl: -3.9, -1.6]; P<0.001). Reductions in AHMDs for Aimovig® 70 mg vs placebo were not statistically significant (difference from placebo -1.2 [95% Cl: -2.4, -0.1]).

    AHMDs=acute headache medication days; CM=chronic migraine; DBTP=double-blind treatment phase; ICHD-3=International Classification of Headache Disorder, 3rd edition;
    MHDs=monthly headache days; MOH=medication overuse headache; Q4W=once every 4 weeks; SC=subcutaneous.

MOH=medication overuse headache.
MONTH 3

In a phase 2 CM study subgroup analysis

Patients had fewer monthly migraine days with Aimovig®, even when other preventives failed*

Change in MMDs between baseline and month 3
Change in MMDs between baseline and month 3

Analysis is exploratory and has not been adjusted for multiple comparisons. No conclusions of statistical or clinical significance can be drawn.

*Preventive medications had failed due to lack of efficacy or intolerance by self-report.

CM=chronic migraine; MMDs=monthly migraine days.

MOH=medication overuse headache.

IMPORTANT SAFETY INFORMATION

Contraindication: Aimovig® is contraindicated in patients with serious hypersensitivity to erenumab-aooe or to any of the excipients. Reactions have included anaphylaxis and angioedema.

Hypersensitivity Reactions: Hypersensitivity reactions, including rash, angioedema, and anaphylaxis, have been reported with Aimovig® in post marketing experience. Most reactions were not serious and occurred within hours of administration, although some occurred more than one week after administration. If a serious or severe reaction occurs, discontinue Aimovig® and initiate appropriate therapy.

Constipation with Serious Complications: Constipation with serious complications has been reported following the use of Aimovig® in the postmarketing setting. There were cases that required hospitalization, including cases where surgery was necessary. The onset of constipation was reported after the first dose in a majority of these cases, but patients also reported later on in treatment. Aimovig® was discontinued in most reported cases. Constipation was one of the most common (up to 3%) adverse reactions reported in clinical studies.

Monitor patients treated with Aimovig® for severe constipation and manage as clinically appropriate. Concurrent use of medications associated with decreased 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 Aimovig® in the postmarketing setting. Many of the patients had pre-existing hypertension or risk factors for hypertension. There were cases requiring pharmacological treatment and, in some cases, hospitalization. Hypertension may occur at any time during treatment but was most frequently reported within seven days of dose administration. In the majority of the cases, the onset or worsening of hypertension was reported after the first dose. Aimovig® was discontinued in many of the reported cases.

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

Raynaud's Phenomenon: Development of Raynaud’s phenomenon and recurrence or worsening of preexisting Raynaud’s phenomenon have been reported in the postmarketing setting following the use of CGRP antagonists, including AIMOVIG. Many of the cases reported serious outcomes, including hospitalizations and disability, generally related to debilitating pain.

AIMOVIG 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 in clinical studies (≥ 3% of Aimovig®-treated patients and more often than placebo) were injection site reactions and constipation.

INDICATION

Aimovig® (erenumab-aooe) is indicated for the preventive treatment of migraine in adults.

Please see Aimovig® full Prescribing Information.

Important Safety Information

Contraindication: Aimovig® is contraindicated in patients with serious hypersensitivity to erenumab-aooe or to any of the excipients. Reactions have included anaphylaxis and angioedema.

Hypersensitivity reactions: Hypersensitivity reactions, including rash, angioedema, and anaphylaxis, have been reported with Aimovig® in post marketing experience. Most reactions were not serious and occurred within hours of administration, although some occurred more than one week after administration. If a serious or severe 

References: 1. Aimovig. Package insert. Amgen Inc; 2025. 2. Goadsby PJ, Reuter U, Hallström Y, et al. A controlled trial of erenumab for episodic migraine. N Engl J Med. 2017;377(22):2123-2132. 3. Goadsby PJ, Reuter U, Hallström Y, et al. One-year sustained efficacy of erenumab for episodic migraine: Results of the STRIVE study. Neurology. 2020;95:e469-e479. doi:10.1212/WNL.0000000000010019.

References: 1. Ashina M, Goadsby PJ, Reuter U, et al. Long-term efficacy and safety of erenumab in migraine prevention: Results from a 5-year, open-label treatment phase of a randomized clinical trial. Eur J Neurol. 2021;28:1716-1725. doi:10.1111/ene.14175. 2. Data on file, Amgen; [Ph 2 EM CSR T14-1.1, January 28, 2016]. 3. Sun H, Dodick DW, Silberstein S, et al. Safety and efficacy of AMG 334 for prevention of episodic migraine: a randomized, double-blind, placebo-controlled, phase 2 trial. Lancet Neurol. 2016;15(4):382-390.

References: 1. Aimovig. Package insert. Amgen Inc; 2025. 2. Goadsby PJ, Reuter U, Hallström Y, et al. A controlled trial of erenumab for episodic migraine. N Engl J Med. 2017;377(22):2123-2132. 3. Data on file, Amgen; [Ph 2 EM CSR, November 25, 2020]. 4. Sun H, Dodick DW, Silberstein S, et al. Safety and efficacy of AMG 334 for prevention of episodic migraine: a randomized, double-blind, placebo-controlled, phase 2 trial. Lancet Neurol. 2016;15(4):382-390. 5. Ashina M, Goadsby PJ, Reuter U, et al. Long-term efficacy and safety of erenumab in migraine prevention: Results from a 5-year, open-label treatment phase of a randomized clinical trial. Eur J Neurol. 2021;28:1716-1725. doi:10.1111/ene.14175.

References: 1. Bröessner G, Reuter U, Bonner J, et al. Achievement of ≥75% and 100% response in patients treated with erenumab: 24-week results from the STRIVE study. Poster presented at: 18th Congress of the International Headache Society; September 7-10, 2017; Vancouver, Canada. 2. Data on file, Amgen; [Ph 2 EM CSR, November 25, 2020]. 3. Sun H, Dodick DW, Silberstein S, et al. Safety and efficacy of AMG 334 for prevention of episodic migraine: a randomized, double-blind, placebo-controlled, phase 2 trial. Lancet Neurol. 2016;15(4):382-390. 4. Data on file, Amgen; [Ph 2 EM CSR T14-4.3.19, January 28, 2016]. 5. Ashina M, Goadsby PJ, Reuter U, et al. Long-term efficacy and safety of erenumab in migraine prevention: Results from a 5-year, open-label treatment phase of a randomized clinical trial. Eur J Neurol. 2021;28:1716-1725. doi:10.1111/ene.14715.

References: 1. Aimovig. Package insert. Amgen Inc; 2025. 2. Tepper SJ, Ashina M, Reuter U, et al. Long-term safety and efficacy of erenumab in patients with chronic migraine: Results from a 52-week, open-label extension study. Cephalalgia. 2020;40(6):543-553. 3. Tepper S, Ashina M, Reuter U, et al. Safety and efficacy of erenumab for preventive treatment of chronic migraine: a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Neurol. 2017;16(6):425-434. 4. Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018;38:1-211. 5. Tepper SJ, Dodick D, Lanteri-Minet M, et al. A Phase 4 Randomized Placebo-Controlled Study to Evaluate the Efficacy and Safety of Erenumab in Adults with Medication Overuse Headache. Poster presented at: American Headache Society 65th Annual Scientific Meeting; June 15-18, 2023; Austin, TX.

Reference: 1. Ashina M, Tepper SJ, Brandes JL, et al. Efficacy and safety of erenumab (AMG 334) in chronic migraine patients with prior preventive treatment failure: a subgroup analysis of a randomized, double-blind, placebo-controlled study. Cephalalgia. 2018;38(10):1611-1621.