Months 4 to 6

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

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Change From Baseline (~8 Monthly Migraine Days) in Mean MMDs Over Months 4 to 61,2,†
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

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

Change in MMDs from baseline
arrow-graphic
fewer migraine days with Aimovig® 70 mg (n = 369)
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fewer migraine days with Aimovig® 140 mg (n = 368)

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.

Recently Released Data: Year 5

Aimovig® demonstrated sustained efficacy with results out to 5 years1,2

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Change From Baseline in Mean MMDs at Month 3 and Year 51-4

N = total number of patients who enter into OLTP.
n = total number of patients with observed monthly migraine days at each visit.

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 19 patients (5.0%) discontinued due to adverse events.1

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).1,2

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.1,2

*Study included additional dosage arms, which were not included in the FDA-approved labeling.2

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

Up to half of Aimovig®-treated patients cut migraine days by at least 50%1,2

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Percentage of Patients Achieving at Least a 50% Reduction From Baseline in MMDs1

≥50% response rate was the secondary endpoint in the phase 3, double-blind, randomized study.1,2

*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

Recently Released Data: Year 5

In a phase 2 EM study

~7 out of 10 Aimovig®-treated patients cut migraine days by at least 50%3,4

y_img_02.2 y_img_02.2
71.2% (n = 99)
of patients receiving Aimovig® 140 mg achieved a ≥50% reduction in monthly migraine days at 5 years3
  • 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 19 patients (5.0%) discontinued due to adverse events.5

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

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Percentage of Patients Achieving at Least a 75% Reduction From Baseline in MMDs1

≥75% response rate is an exploratory analysis and has not been adjusted for multiple comparisons. No conclusions of statistical or clinical significance can be drawn.1

Recently Released Data: Year 5

In a phase 2 EM study

~5 out of 10 Aimovig®-treated patients cut migraine days by at least 75%2,3

y_img_02.2 y_img_02.2
47.5% (n = 66)
of patients receiving Aimovig® 140 mg achieved a ≥75% reduction in monthly migraine days at 5 years2
  • 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 19 patients (5.0%) 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; OLE = open label extension; Ph = phase.

Months 4 to 6

In a phase 3 EM study subgroup analysis

Patients had relief with Aimovig®, even when their oral preventives failed1

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Change in Mean MMDs Between Baseline (~9 MMDs) and Months 4 to 61-3

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
42.4% (405/955)
of patients had previously received oral preventive treatment, which was discontinued prior to the enrollment1
of those patients
>90% (370/405)
reported treatment failure by self-report as recorded by the investigator at enrollment, due to
insufficient
efficacy

(64.7%; 262/405)1
and/or
unacceptable
tolerability

(50.6%; 205/405)1
  • 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,*

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*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.

MMDs = monthly migraine days; SNRI = serotonin–norepinephrine reuptake inhibitor.