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Indication Aimovig® is indicated for the preventive treatment of migraine in adults.

  • MMDs
  • RESPONSE RATES
  • PRIOR PREVENTIVES
  • Ph 3 EM Months 4 to 6
  • Ph 2 EM Year 5
Months 4 to 6

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

Migraine-free days with Aimovig® (erenumab-aooe) compared to placebo
Migraine-free days with Aimovig® (erenumab-aooe) compared to placebo
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.1,2

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.2

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

Year 1

In the phase 3 EM active treatment phase

Efficacy was maintained at 1 year of treatment3

Efficacy of Aimovig® (erenumab-aooe) 70 mg and 140 mg
ph32year1_mobile
Study Information

Following the 24-week DBTP, patients were re-randomized to receive Aimovig® 70 mg (n = 421) or 140 mg (n = 424) during the ATP, with re-randomization stratified by treatment groups assigned during the DBTP.3

ATP = active treatment phase; DBTP = double-blind treatment phase; EM = episodic migraine; MMDs = monthly migraine days; Ph = phase.
Year 5

Aimovig® demonstrated sustained efficacy with results out to 5 years

MMDs at baseline: 8.7 days for all groups1

Sustained efficacy of Aimovig® (erenumab-aooe)
Sustained efficacy of Aimovig® (erenumab-aooe)

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.3

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

*Study included additional dosage arms, which were not included in the FDA-approved labeling.3

DBTP = double-blind treatment phase; EM = episodic migraine; MMDs = monthly migraine days; OLTP = open-label treatment phase; Ph = phase.
  • ≥50% Response
  • ≥75% Response
Months 4 to 6

In a phase 3 EM study

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

Response rate of patients treated with Aimovig® (erenumab-aooe) in months 4 to 6
Sustained efficacy of Aimovig® (erenumab-aooe)
  • ≥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%

Response rate of patients treated with Aimovig® (erenumab-aooe) in year 5
Response rate of patients treated with Aimovig® (erenumab-aooe) in year 5
  • 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

DBTP = double-blind treatment phase; EM = episodic migraine; MMDs = monthly migraine days; OLTP = open-label treatment phase; Ph = phase.
Months 4 to 6

In a phase 3 EM study exploratory analysis

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

Patients being treated with Aimovig® (erenumab-aooe) 70 mg and 140 mg vs placebo in months 4 to 6
Patients being treated with Aimovig® (erenumab-aooe) 70 mg and 140 mg vs placebo in months 4 to 6
  • ≥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%

Patients being treated with Aimovig® (erenumab-aooe) 140 mg in year 5
Patients being treated with Aimovig® (erenumab-aooe) 140 mg in year 5
  • 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

DBTP = double-blind treatment phase; EM = episodic migraine; MMDs = monthly migraine days; OLTP = open-label treatment phase; Ph = phase.
  • Monthly Migraine Days
  • Subgroup Population
Months 4 to 6

In a phase 3 EM study subgroup analysis

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

Response rate of patients treated with Aimovig® (erenumab-aooe) in year 5
Preventive Medication Failure_mobile

Subgroup 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.1

EM = episodic migraine; MMDs = monthly migraine days; Ph = phase.

Efficacy was evaluated in patients who failed oral preventives1

In the overall study population

Efficacy evaluation of patients who failed oral preventives Efficacy evaluation of patients who failed oral preventives
  • This represents 39% (370/955) of the total population1
    • ≥1 preventive medication failure = 38.7% (370/955) of total study population1
    • ≥2 preventive medication failure = 16.9% (161/955) of total study population1
  • Subgroups were defined based on these prior oral preventive treatment failures1

Prior treatments failed1,*

Efficacy evaluation of prior treatments failed in patients Efficacy evaluation of prior treatments failed in patients

*Categories are not mutually exclusive and patients may contribute to more than one category.

Atenolol, bisoprolol, metoprolol, nadolol, nebivolol, pindolol, propranolol, and timolol.

Venlafaxine, desvenlafaxine, duloxetine, and milnacipran.

CM = chronic migraine; MMDs = monthly migraine days; Ph = phase; SNRI = serotonin-norepinephrine reuptake inhibitor.

INDICATION

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

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.

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.

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® (erenumab-aooe) Prescribing Information. Thousand Oaks, CA: Amgen Inc; 2021. 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. 4. Data on file, Amgen; 2024.

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. 4. Data on file, Amgen; 2024.

References: 1. Aimovig® (erenumab-aooe) Prescribing Information. Thousand Oaks, CA: Amgen Inc; 2021. 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. 6. Data on file, Amgen; 2024.

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. 6. Data on file, Amgen; 2024.

References: 1. Goadsby PJ, Paemeleire K, Bröessner G, et al. Efficacy and safety of erenumab (AMG 334) in episodic migraine patients with prior preventive treatment failure: a subgroup analysis of a randomized, double-blind, placebo-controlled study. Cephalalgia. 2019. doi:10.1177/0333102419835459. 2. Goadsby PJ, Paemeleire K, Bröessner G, et al. Efficacy of erenumab in subjects with episodic migraine with prior preventive treatment failure(s). Presented at: 18th Congress of the International Headache Society; September 7-10, 2017; Vancouver, Canada. 3. Data on file, Amgen; [Ph 3 EM CSR Table 10-3, February 20, 2017]. 4. Data on file, Amgen; 2024.

References: 1. Goadsby PJ, Paemeleire K, Bröessner G, et al. Efficacy and safety of erenumab (AMG 334) in episodic migraine patients with prior preventive treatment failure: a subgroup analysis of a randomized, double-blind, placebo-controlled study. Cephalalgia. 2019. doi:10.1177/0333102419835459. 2. Data on file, Amgen; 2024.