General Information

Aimovig (erenumab-aooe) is a calcitonin gene-related peptide receptor antagonist.

Aimovig is specifically indicated for the preventative treatment of migraine in adults.

Aimovig is supplied as an injection for subcutaneous use. The recommended dosage of Aimovig is 70 mg injected subcutaneously once monthly. Some patients may benefit from a dosage of 140mg injected subcutaneously once monthly, which is administered as two consecutive subcutaneous injections of 70mg each. If a dose of Aimovig is missed, administer as soon as possible. Thereafter, Aimovig can be scheduled monthly from the date of the last dose.

Clinical Results

FDA Approval

The FDA approval of Aimovig as a preventive treatment of episodic or chronic migraine was based on three randomized, 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 headache days 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.

Study 1 was a randomized, multi-center, 6-month, placebo-controlled, double-blind study evaluating 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, ergotamine derivatives) and NSAIDs during the study. The primary efficacy endpoint was the change from baseline in mean monthly migraine days over months 4 to 6. Subjects in the erenumab 70 mg and 140 mg treatment arms experienced reductions of 3.2 and 3.7 days from baseline in monthly migraine days, respectively, as compared to a 1.8-day reduction in the placebo arm.

Study 2 was a randomized, multi-center, 3-month, placebo-controlled, double-blind study evaluating Aimovig for the preventive treatment of episodic migraine. A total of 577 patients with a history of episodic migraine were randomized to receive either Aimovig 70 mg (N = 286) or placebo (N = 291) by subcutaneous injection once monthly for 3 months. Patients were allowed to use acute headache treatments including migraine-specific medications (i.e., triptans, ergotamine derivatives) and NSAIDs during the study. The primary efficacy endpoint was the change from baseline in monthly migraine days at month 3. The subjects receiving erenumab experienced a statistically significant 2.9-day reduction from baseline in monthly migraine days, as compared to a 1.8-day reduction in the placebo arm.

Study 3 was a randomized, multi-center, 3-month, placebo-controlled, double-blind study evaluating Aimovig as a preventive treatment of chronic migraine. A total of 667 patients with a history of chronic migraine with or without aura were randomized to receive Aimovig 70 mg (N = 191), Aimovig 140 mg (N = 190), or placebo (N = 286) by subcutaneous injections once monthly for 3 months. Patients were allowed to use acute headache treatments including migraine-specific medications (i.e., triptans, ergotamine derivatives) and NSAIDs during the study. The primary efficacy endpoint was the change from baseline in monthly migraine days at month 3. The reduction in migraine days was statistically significant for both the 70 mg and 140 mg doses. Patients experienced a 6.6-day reduction from baseline in monthly migraine days in each of the erenumab treatment arms as compared to a 4.2-day reduction in the placebo arm.