Mutagenesis

Genetic toxicology studies of erenumab-aooe have not been conducted.

Impairment of Fertility

Mating studies have not been conducted on erenumab-aooe. No histopathological changes in male or femalereproductive organs were observed in monkeys administered erenumab-aooe (0, 25, or 150 mg/kg) by

subcutaneous injection twice weekly for up to 6 months. Serum erenumab-aooe exposures (AUC) at the higherdose tested were more than 100 times that in humans at a dose of 140 mg once monthly.

14 CLINICAL STUDIES

The efficacy of AIMOVIG was eva luated as a preventive treatment of episodic or chronic migraine in threerandomized, double-blind, placebo-controlled studies: two studies in patients with episodic migraine (4 to 14

migraine days per month) (Study 1 and Study 2) and one study in patients with chronic migraine (≥ 15 headachedays per month with ≥ 8 migraine days per month) (Study 3). The studies enrolled patients with a history of

migraine, with or without aura, according to the International Classification of Headache Disorders (ICHD-III)diagnostic criteria.

Episodic Migraine

Study 1 (NCT 02456740) was a randomized, multi-center, 6-month, placebo-controlled, double-blind studyeva luating AIMOVIG for the preventive treatment of episodic migraine. A total of 955 patients with a history of

episodic migraine were randomized to receive either AIMOVIG 70 mg (N = 317), AIMOVIG 140 mg(N = 319), or placebo (N = 319) by subcutaneous injection once monthly (QM) for 6 months. Patients were

allowed to use acute headache treatments including migraine-specific medications (i.e., triptans, ergotaminederivatives) and NSAIDs during the study.

The study excluded patients with medication overuse headache as well as patients with myocardial infarction,stroke, transient ischemic attacks, unstable angina, coronary artery bypass surgery, or other revascularization

procedures within 12 months prior to screening.

The primary efficacy endpoint was the change from baseline in mean monthly migraine days over months 4 to6. Secondary endpoints included the achievement of a ≥ 50% reduction from baseline in mean monthlymigraine days over months 4 to 6 (“≥ 50% MMD responders”), the change from baseline in mean monthly

acute migraine-specific medication days over months 4 to 6, and the change from baseline in mean MigrainePhysical Function Impact Diary (MPFID) over months 4 to 6. The MPFID measures the impact of migraine on

everyday activities (EA) and physical impairment (PI) using an electronic diary administered daily. MonthlyMPFID scores are averaged over 28 days, including days with and without migraine; scores are scaled from 0 to

100. Higher scores indicate worse impact on EA and PI. Reductions from baseline in MPFID scores indicateimprovement.

A total of 858 (90%) patients completed the 6-month double-blind study. Patients had a median age of 42 years(range: 18 to 65 years), 85% were female, and 89% were white. Three percent of patients were taking

concomitant preventive treatments for migraine. The mean migraine frequency at baseline was approximately 8migraine days per month and was similar across treatment groups.

AIMOVIG treatment demonstrated statistically significant improvements for key efficacy endpoints comparedto placebo, as summarized in Table 3.

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