3 months in the migraine studies (Studies 1, 2, and 3).

Table 1: Adverse Reactions Occurring with an Incidence of at Least 2% for Either Dose of AIMOVIGand at Least 2% Greater than Placebo During the First 3 Months in Studies 1, 2, and 3

Adverse Reaction

AIMOVIG

70 mg Once Monthly

N = 787

%

AIMOVIG

140 mg Once Monthly

N = 507

%

Placebo

N = 890

%

Injection site reactionsa

 6 5 3

Constipation 1 3 1

Cramps, muscle spasms < 1 2 < 1 a

Injection site reactions include multiple adverse reactions related terms, such as injection site pain and injection site erythema.In Studies 1, 2, and 3, 1.3% of patients treated with AIMOVIG discontinued double-blind treatment because of

adverse events. The most frequent injection site reactions were injection site pain, injection site erythema, andinjection site pruritus.

6.2 Immunogenicity

As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation,including neutralizing antibodies, is highly dependent on the sensitivity and specificity of the assay.

Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may beinfluenced by several factors including assay methodology, sample handling, timing of sample collection,

concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodiesto erenumab-aooe in the studies described below with the incidence of antibodies in other studies or to other

products may be misleading.

The immunogenicity of AIMOVIG has been eva luated using an immunoassay for the detection of bindinganti-erenumab-aooe antibodies. For patients whose sera tested positive in the screening immunoassay, an in

vitro biological assay was performed to detect neutralizing antibodies.

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8In controlled studies with AIMOVIG, the incidence of anti-erenumab-aooe antibody development was6.2% (48/778) in patients receiving AIMOVIG 70 mg once monthly (2 of whom had in vitro neutralizing

activity) and 2.6% (13/504) in patients receiving AIMOVIG 140 mg once monthly (none of whom had in vitroneutralizing activity).

The neutralizing anti-erenumab-aooe antibody positive rate may be underestimatedbecause of limitations of the assay. Although these data do not demonstrate an impact of anti-erenumab-aooeantibody development on the efficacy or safety of AIMOVIG in these patients, the available data are too limited

to make definitive conclusions.

USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

There are no adequate data on the developmental risk associated with the use of AIMOVIG in pregnant women.

No adverse effects on offspring were observed when pregnant monkeys were administered erenumab-aooethroughout gestation (see Data). Serum erenumab-aooe exposures in pregnant monkeys were greater than those

in humans at clinical doses.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage inclinically recognized pregnancies is 2%-4% and 15%-20%, respectively. The estimated rate of major birth