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A total of 631 (95%) patients completed the 3-month double-blind study. Patients had a median age of 43 years(range: 18 to 66 years), 83% were female, and 94% were white. The mean migraine frequency at baseline was

approximately 18 migraine days per month and was similar across treatment groups.

AIMOVIG treatment demonstrated statistically significant improvements for key efficacy outcomes comparedto placebo, as summarized in Table 5.

Table 5: Efficacy Endpoints at Month 3 in Study 3

AIMOVIG

70 mg Once Monthly

N = 188

AIMOVIG

140 mg Once Monthly

N = 187

Placebo

N = 281

Monthly Migraine Days (MMD)

Change from baseline -6.6 -6.6 -4.2

Difference from placebo -2.5 -2.5

p-value < 0.001 < 0.001

≥ 50% MMD responders

% Responders 39.9% 41.2% 23.5%

Difference from placebo 16.4% 17.7%

Odds ratio relative to placebo 2.2 2.3

p-value < 0.001 < 0.001

Monthly acute migraine-specific medication days

Change from baseline -3.5 -4.1 -1.6

Difference from placebo -1.9 -2.6

p-value < 0.001 < 0.001

Figure 5: Change from Baseline in Monthly Migraine Days in Study 3aaLeast-square means and 95% confidence intervals are presented.

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Figure 6 shows the distribution of change from baseline in monthly migraine days at month 3 in bins of 3 daysby treatment group. A treatment benefit over placebo for both doses of AIMOVIG is seen across a range of

changes from baseline in migraine days.

Figure 6: Distribution of Change from Baseline in Monthly Migraine Days at Month 3 by TreatmentGroup in Study 3

Figure excludes patients with missing data.

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

AIMOVIG (erenumab-aooe) injection is a sterile, clear to opalescent, colorless to light yellow solution forsubcutaneous administration.

The needle shield within the white cap of the AIMOVIG prefilled autoinjector and gray needle cap of theAIMOVIG prefilled syringe contain dry natural rubber (a derivative of latex). Each single-dose prefilled

SureClick® autoinjector or single-dose prefilled syringe of AIMOVIG contains a Type 1 glass syringe andstainless steel needle and delivers 1 mL of 70 mg/mL solution.

AIMOVIG is supplied as follows:

SureClick® Autoinjector

Pack of 1 autoinjector: 70 mg/mL single-dose prefilled autoinjector

NDC 55513-841-01

Pack of 2 autoinjectors: 140 mg/2 mL (2 x 70 mg/mL single-dose prefilled autoinjectors)

NDC 55513-841-02

Syringe

Pack of 1 syringe: 70 mg/mL single-dose prefilled syringe

NDC 55513-840-01

Pack of 2 syringes: 140 mg/2 mL (2 x 70 mg/mL single-dose prefilled syringes)

NDC 55513-840-02

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16.2 Storage and Handling

Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until time of use.

If removed from the refrigerator, AIMOVIG should be kept at room temperature (up to 25°C [77°F]) in theoriginal carton and must be used within 7 days. Throw away AIMOVIG that has been left at room

temperature for more than 7 days.

Do not freeze.

Do not shake.

17 PATIENT COUNSELING INFORMATION