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.

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.


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 

Study design schematic for study in patients with episodic migraine Study design schematic for study in patients with episodic migraine

 

Primary endpoint2

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

Secondary endpoints2

  • 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 a 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 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


Study design schematic for study in patients with episodic migraine Study design schematic for study in patients with episodic migraine

Primary endpoint7

  • The change from baseline in mean monthly migraine days at month 3

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 preventive 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 preventive 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. a. At least 2 pain features described as unilateral, throbbing, moderate to severe, or exacerbated with physical activity
      2. b. Nausea and/or vomiting
      3. c. Photophobia and phonophobia
Or
  • A migraine with aura and meeting both of the criteria below:
    1. a. At least 1 fully reversible aura symtom (visual, sensory, speech and/or language, retinal, or brainstem)
    2. b. 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*
Line graph of primary endpoint results for study in patients with episodic migraine with a baseline of approximately 8 monthly migraine days Line graph of primary endpoint results for study in patients with episodic migraine with a baseline of approximately 8 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 mean 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 +
Secondary outcome measure
Change from baseline in mean monthly migraine days at month 37
Change from baseline in mean monthly migraine days*
Line graph of primary endpoint results for study in patients with chronic migraine with a baseline of approximately 18  monthly migraine days Line graph of primary endpoint results for study in patients with chronic migraine with a baseline of approximately 18  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 mean between Aimovig® and placebo assessed at month 3 (primary outcome measure) was < 0.001 for both Aimovig® dose 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 +
Primary 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
Bar graph of secondary endpoint results for study in patients with episodic migraine with a baseline of approximately 8 monthly migraine days Bar graph of secondary endpoint results for study in patients with episodic migraine with a baseline of approximately 8 monthly migraine days
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
Bar chart of secondary endpoint results for study in patients with chronic migraine with a baseline of approximately 18 monthly migraine days Bar chart of secondary endpoint results for study in patients with chronic migraine with a baseline of approximately 18 monthly migraine days
~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% CI: 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 +
Primary 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
Bar chart of secondary endpoint results in patients for study  in patients with episodic migraine with a baseline of approximately 8 monthly migraine days Bar chart of secondary endpoint results in patients for study  in patients with episodic migraine with a baseline of approximately 8 monthly migraine days
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
Bar chart of secondary endpoint results for study in patients with chronic migraine with a baseline of approximately 18 monthly migraine days Bar chart of secondary endpoint results for study in patients with chronic migraine with a baseline of approximately 18 monthly migraine days
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

Table of most common adverse reactions occurring with Aimovig® (erenumab-aooe) Table of most common adverse reactions occurring with Aimovig® (erenumab-aooe)

*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

Pie chart of patients receiving Aimovig® (erenumab-aooe) who completed the 6-month episodic migraine study
Pie chart of patients receiving Aimovig® (erenumab-aooe) who completed the 6-month episodic migraine study.
Pie chart of patients receiving Aimovig® (erenumab-aooe) who completed the 3-month chronic migraine study.
 

QM = once monthly.

Indication

Aimovig® 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.

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.

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.