Reference ID: 4264882 

 

Table 3: Efficacy Endpoints Over Months 4 to 6 in Study 1

 AIMOVIG

70 mg Once Monthly

N = 312

AIMOVIG

140 mg Once Monthly

N = 318

Placebo

N = 316

Monthly Migraine Days (MMD)

Change from baseline -3.2 -3.7 -1.8

Difference from placebo -1.4 -1.9

p-value < 0.001 < 0.001

≥ 50% MMD responders

% Responders 43.3% 50.0% 26.6%

Difference from placebo 16.7% 23.4%

Odds ratio relative to placebo 2.1 2.8

p-value < 0.001 < 0.001

Monthly acute migraine-specific medication days

Change from baseline -1.1 -1.6 -0.2

Difference from placebo -0.9 -1.4

p-value < 0.001 < 0.001

Figure 1: Change from Baseline in Monthly Migraine Days in Study 1a

a

Least-square means and 95% confidence intervals are presented.

Figure 2 shows the distribution of change from baseline in mean monthly migraine days over months 4 to 6 inbins of 2 days by treatment group. A treatment benefit over placebo for both doses of AIMOVIG is seen across

a range of changes from baseline in monthly migraine days.

Page 8 of 14

Reference ID: 4264882 

Figure 2: Distribution of Change from Baseline in Mean Monthly Migraine Days over Months 4 to 6 byTreatment Group in Study 1

Figure excludes patients with missing data.

Compared to placebo, patients treated with AIMOVIG 70 mg once monthly and 140 mg once monthly showedgreater reductions from baseline in mean monthly MPFID everyday activity scores averaged over months 4 to 6

[difference from placebo: -2.2 for AIMOVIG 70 mg and -2.6 for AIMOVIG 140 mg; p-value < 0.001 for both],and in mean monthly MPFID physical impairment scores averaged over months 4 to 6 [difference fromplacebo: -1.9 for AIMOVIG 70 mg and -2.4 for AIMOVIG 140 mg; p-value < 0.001 for both].

Study 2 (NCT 02483585) was a randomized, multi-center, 3-month, placebo-controlled, double-blind studyeva luating 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) bysubcutaneous 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 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 revascularizationprocedures within 12 months prior to screening.

The primary efficacy endpoint was the change from baseline in monthly migraine days at month 3. Secondaryendpoints included the achievement of a ≥ 50% reduction from baseline in monthly migraine days (“≥ 50%

MMD responders”), the change from baseline in monthly acute migraine-specific medication days at month 3,and the proportion of patients with at least a 5-point score reduction from baseline in MPFID at month 3.

A total of 546 (95%) patients completed the 3-month double-blind study. Patients had a median age of 43 years(range: 18 to 65 years), 85% were female, and 90% were white. Six to seven percent of patients were taking