Important Safety Information

  • 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.


Indication

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

Aimovig was studied in a broad range of patients with 4 or more monthly migraine days1*

Clinical trials included patients with episodic and chronic migraine1

Aimovig was evaluated for prevention of episodic migraine in patients with 4 to 14 monthly migraine days in a randomized, multicenter, 24-week, placebo-controlled, double-blind study. The mean migraine frequency at baseline was ~8 monthly migraine days across treatment groups.1,2 

 

Primary endpoint2

  • The change in mean monthly migraine days between baseline and months 4 to 6

Secondary endpoint2

  • Achievement of a ≥ 50% reduction in mean monthly migraine days from baseline (≥ 50% responders) during months 4 to 6

  • Change in mean monthly acute migraine-specific medication (ergotamine derivatives and triptans) treatment days between baseline and months 4 to 6

Select prespecified exploratory endpoints3

  • Change from baseline in mean monthly migraine days at assessment time points

  • Achievement of at least 75% reduction from baseline in mean monthly migraine days during months 4 to 6

  • Change from baseline in mean monthly acute migraine-specific medication treatment days at assessment time points3

Inclusion criteria1

  • Patients with a history of migraine, with or without aura, for a duration of ≥ 12 months and 4 to 14 migraine days per month, on average across the 3 months prior to screening

  • Patients were allowed to use acute headache treatments, including triptans, ergotamine derivatives, and NSAIDs, during the study

  • < 15 headache days per month on average across the 3 months prior to screening

Exclusion criteria3

  • Patients with medication overuse headache

  • Elderly patients (> 65 years)

  • History of cluster headache or hemiplegic migraine headache

  • Patients who had no therapeutic response to > 2 previous migraine preventive migraine treatment categories after an adequate therapeutic trial

NSAIDs = nonsteroidal anti-inflammatory drugs; QM = once monthly; SC = subcutaneously.

*Migraine Day2 =
  • Any calendar day in which the subject experiences a migraine with or without aura, lasting ≥ 30 minutes, and meeting at least one of the following criteria:
    • ≥ 2 pain features described as unilateral, throbbing, moderate to severe, or exacerbated with exercise/physical activity
    • ≥ 1 of the following associated symptoms: nausea and/or vomiting; and photophobia and phonophobia
  • If the subject took a migraine-specific medication, it was counted as a migraine day.
Headache Day2 =
  • Any calendar day affected by a migraine headache (including an aura-only event treated with acute migraine-specific medication), or a non-migraine headache (headache that lasts at least 30 minutes), or a headache for which an acute headache treatment was taken.
No Therapeutic Response2 =
  • No reduction in headache frequency, duration, or severity after administration of the medication for at least 6 weeks at the generally accepted therapeutic dose(s) based on the investigator’s assessment. The following scenarios do not constitute lack of therapeutic response:
    • Lack of sustained response to a medication
    • Failure to tolerate a therapeutic dose

Aimovig was evaluated for prevention of chronic migraine in patients with 15 or more headache days per month, including 8 or more migraine days per month, in a randomized, multicenter, 12-week, placebo-controlled, double-blind study. The mean migraine frequency at baseline was ~18 migraine days across treatment groups.1,7



Primary endpoint7

  • Change from baseline in mean monthly migraine days at month 31,2

Secondary endpoints7

  • Achievement of a ≥ 50% reduction in mean monthly migraine days from baseline (≥ 50% responders) at month 3

  • Change from baseline in mean monthly acute migraine-specific medication (ergotamine derivatives and triptans) treatment days at month 3

Select prespecified exploratory endpoints7

  • Change from baseline in mean monthly migraine days at assessment time points other than month 3

  • Achievement of ≥ 50% reduction in mean monthly migraine days from baseline at assessment time points other than month 3

Inclusion criteria1

  • Patients with a history of migraine, with or without aura and ≥ 15 headache days/month, of which ≥ 8 were migraine days

  • Patients were allowed to use acute headache treatments, including triptans, ergotamine derivatives, and NSAIDs, during the study

Exclusion criteria1,7

  • Patients with concurrent use of migraine preventative treatments

  • Elderly patients (> 65 years)

  • Patients with myocardial infarction, stroke, transient ischaemic attacks, unstable angina, coronary artery bypass surgery, or other revascularization procedures within 12 months prior to screening

  • History of cluster or hemiplegic migraine headache

  • Patients with opioid overuse

  • Patients who had no therapeutic response to > 3 previous migraine preventative migraine treatment categories due to lack of efficacy, whereas there was no limit to the number of previous failures for poor tolerability

NSAIDs = nonsteriodal anti-inflammatory drugs; QM = once monthly; SC = subcutaneously.

*Migraine Day=
  • Any calendar day a patient experiences:
    • A migraine without aura, lasting at least 4 continuous hours, and meeting at least one of the following criteria:
      1. At least 2 pain features described as unilateral, throbbing, moderate to severe, or exacerbated with physical activity
      2. Nausea and/or vomiting
      3. Photophobia and phonophobia
Or
  • A migraine with aura and meeting both of the criteria below:
    1. At least 1 fully reversible aura symtom (visual, sensory, speech and/or language, retinal, or brainstem)
    2. Aura is accompanied, or followed within 60 minutes, by headache lasting for at least 4 continuous hours
Or
  • Any calendar day a patient took a triptan or ergot derivative
Headache Day =
  • Any calendar day on which the patient experienced a qualified migraine or non-migraine headache (onset, continuation, or recurrence of the headache) lasting at least 4 hours continuously or a headache of any duration for which acute medication was given to treat headache pain.
No Therapeutic Response =
  • No reduction in headache frequency, duration, or severity after administration of the medication for at least 6 weeks at the generally accepted therapeutic dose(s) based on the investigator’s assessment. Subjects do not meet this exclusion criteria if:
    • The subject discontinued the medication prior to achieving a therapeutic response due to adverse events related to the medication.
    • In the investigator’s opinion, the subject did not receive an adequate dose of the medication for at least 6 weeks.

Aimovig reduced monthly migraine days, including in patients with prior preventive medication failure1

Click here to see episodic migraine study design +
Primary outcome measure
Change from baseline in mean monthly migraine days over months 4 to 61,2
Change from baseline in mean monthly migraine days*

*Least-squares mean and 95% confidence intervals are presented.

Earliest post-baseline, pre-specified assessment.

The P value for the difference in least-square means between Aimovig and placebo assessed as the average over months 4 to 6 (primary outcome measure) was < 0.001 for both Aimovig dose groups. 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).

Patients with a baseline of ~8 monthly migraine days had a reduction of up to 3.7 days on Aimovig™1

Monthly migraine day reductions in patients with prior preventive medication failure4


In a subgroup analysis of patients for whom 1 or more preventive medications had failed due to lack of efficacy or intolerance by self-report, and who had a baseline of ~9 monthly migraine days, the following treatment arms showed a reduction in monthly migraine days from baseline:

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

Click here to see chronic migraine study design +
Primary outcome measure
Change from baseline in mean monthly migraine days at month 37
Change from baseline in mean monthly migraine days*

*Least-squares mean and 95% confidence intervals are presented.

Earliest post-baseline, pre-specified assessment.

The P value for the difference in least-squares means between Aimovig and placebo assessed at month 3 (primary outcome measure) was < 0.001 for both Aimovigdose groups. For Aimovig 70 mg, the difference from placebo was ‒2.5 (95% CI: ‒3.5, ‒1.4). For Aimovig 140 mg, the difference from placebo was ‒2.5 (95% CI: ‒3.5, ‒1.4).

Patients with a baseline of ~18 monthly migraine days had a reduction of up to 6.6 days on Aimovig™1

Monthly migraine day reductions in patients with prior preventive medication failure8


In a subgroup analysis of patients for whom 1 or more preventive medications had failed due to lack of efficacy or intolerance by self-report, and who had a baseline of ~18 monthly migraine days, the following treatment arms showed a reduction in monthly migraine days from baseline:

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

Aimovig reduced migraine frequency by at least 50% for many patients1

Click here to see episodic migraine study design +
Secondary outcome measures
Achievement of a ≥ 50% reduction in mean monthly migraine days from baseline during months 4 to 62 
Proportion of patients achieving at least a 50% reduction in mean monthly migraine days1
Up to half of patients achieved at least a 50% reduction in monthly migraine days with Aimovig™2

*Odds of achieving a ≥ 50% reduction were significantly higher (2.1, 95% CI: 1.5, 3.0) for the Aimovig 70 mg group than for the placebo group (P < 0.001).
Odds of achieving a ≥ 50% reduction were significantly higher (2.8, 95% CI: 2.0, 3.9) for the Aimovig 140 mg group than for the placebo group (P < 0.001).

Click here to see chronic migraine study design +
Secondary outcome measures
Achievement of a ≥ 50% reduction in mean monthly migraine days from baseline at month 31,7
Proportion of patients achieving at least a 50% reduction in mean monthly migraine days from baseline at month 3
~40% of patients achieved at least a 50% reduction in monthly migraine days with Aimovig™1,7

*Odds of achieving a ≥ 50% reduction were significantly higher (2.2, 95% CI: 1.5, 3.3) for the Aimovig 70 mg group than for the placebo group (P < 0.001).

Odds of achieving a ≥ 50% reduction were significantly higher (2.3, 95%: 1.6, 3.5) for the Aimovig 140 mg group than for the placebo group (P < 0.001).

Aimovig reduced acute migraine-specific medication days1

Click here to see episodic migraine study design +
Secondary outcome measures
Change from baseline in mean monthly acute migraine-specific medication days during months 4 to 61,2
Change from baseline in mean monthly acute migraine-specific medication days during months 4 to 6
Patients had up to 1.6 fewer acute migraine-specific medication* days each month from a baseline of ~3.4 with Aimovig™2

*Acute medication was migraine-specific and included triptans and ergotamine derivatives.
Differences from placebo of ‒0.9 (95% CI: ‒1.2, ‒0.6) and ‒1.4 (95% CI: ‒1.7, ‒1.1) were seen for Aimovig 70 mg and 140 mg, respectively (P < 0.001)

Reductions in acute migraine-specific medication days in patients with prior preventive medication failure4


In a subgroup analysis of patients for whom 1 or more preventive medications had failed due to lack of efficacy or intolerance by self-report, and who had a baseline of ~4.7 acute migraine-specific medication days per month, the following treatment arms showed a reduction in acute migraine-specific medication days from baseline:

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

Click here to see chronic migraine study design +
Secondary outcome measures
Change from baseline in mean monthly acute migraine-specific medication days at month 31,7
Change from baseline in mean monthly acute migraine-specific medication days at month 3
Patients had up to 4 fewer acute migraine-specific medication* days each month from a baseline of ~9.4 with Aimovig™1,7

*Acute medication was migraine-specific and included triptans and ergotamine derivatives.

Differences from placebo of ‒1.9 (95% CI: ‒2.6, ‒1.2) and 2.6 (95% CI: ‒3.3, ‒1.8) were seen for Aimovig 70 mg and 140 mg, respectively (P <0.001)

Reductions in acute migraine-specific medication days in patients with prior preventive medication failure8


In a subgroup analysis of patients for whom 1 or more preventive medications had failed due to lack of efficacy or intolerance by self-report, and who had a baseline of ~10.7 acute migraine-specific medication days per month, the following treatment arms showed a reduction in acute migraine-specific medication days from baseline:

Safety across clinical trials

In phase 2 and phase 3 clinical studies, 2,184 patients with migraine received at least 1 dose of Aimovig™1

*Injection site reactions include multiple preferred terms, such as injection site pain and injection site erythema.

In clinical trials, up to 95% of patients were able to stay on Aimovig™6,7

QM = once monthly

Indication

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

Important Safety Information

Please see Aimovig full Prescribing Information.

References: 1. Aimovig™ (erenumab-aooe) prescribing information, Amgen. 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. Protocol for: A controlled trial of erenumab for episodic migraine. N Engl J Med. 2017;377(22):2123-2132. 4. Goadsby PJ, Paemeleire K, Broessner G, et al. Efficacy of erenumab in subjects with prior preventive treatment failure(s). Oral presentation at 18th Congress of the International Headache Society; September 7-10, 2017; Vancouver, Canada. 5. Brossner G, Reuter U, Dodick D, 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. 6. Goadsby PJ, Reuter U, Hallström Y, et al. Supplement to: A controlled trial of erenumab for episodic migraine. N Engl J Med. 2017;377(22):2123-2132. 7. 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. 8. Ashina M, Tepper S, Brandes JL, et al. Efficacy of erenumab (a fully human mAB targeting the CGRP receptor) in chronic migraine patients with prior treatment failure: a subgroup analysis of the phase 2, randomized, double-blind, placebo controlled study. Poster presented at: 18th Congress of the International Headache Society; September 7–10, 2017; Vancouver, Canada. 9. Brandes JL, Dolezil D, Freeman MC, et al. Chronic migraine treatment with erenumab: responder rates. Poster presented at: American Headache Society, 59th Annual Scientific Meeting; June 8–11, 2017; Boston, MA.