in score at Month 3. Scoresare scaled from 0 to 100, with higher scores indicating less impact of migraine on daily activities.
In Study 3, a total of 1113 patients (946 female, 167 male) ranging in age from 18 to 65 years, were randomized. A total of1037 patients completed the 3-month double-blind phase. The mean number of monthly migraine headache days at
baseline was approximately 19.
EMGALITY 120 mg demonstrated statistically significant improvement for the mean change from baseline in the numberof monthly migraine headache days over the 3-month treatment period, and in the mean percentage of patients reachingat least 50% reduction from baseline in the number of monthly migraine headache days over the 3-month treatment period, as summarized in Table 3. EMGALITY treatment with the 240 mg once-monthly dose showed no additional benefit
over the EMGALITY 120 mg once-monthly dose.
Table 3: Efficacy Endpoints in Study 3
EMGALITY
120 mg
N = 273
Placebo
N =538
Monthly Migraine Headache Days (over Months 1 to 3)
Baseline migraine headache days 19.4 19.6
Mean change from baseline -4.8 -2.7
Difference from placebo* -2.1
≥50% Migraine Headache Days Responders (over Months 1 to 3)
% Responders* 28% 15%
a N = 252 for EMGALITY 120 mg and N = 494 for placebo.
* p<0.001
Study 3 utilized a sequential testing procedure to control the Type-I error rate for the multiple secondary endpoints. Oncea secondary endpoint failed to reach the required level for statistical significance, formal hypothesis testing wasterminated for subsequent endpoints, and p-values were considered nominal only. In Study 3, EMGALITY 120 mg wasnot significantly better than placebo for the proportion of patients with ≥75% or 100% reduction in migraine headachedays. Patients treated with EMGALITY 120 mg showed a nominally greater reduction in the number of monthly migraineheadache days that acute medication was taken (-4.7 for EMGALITY 120 mg vs. -2.2 for placebo; nominal p-value<0.001), and the mean change from baseline in the MSQ Role Function-Restrictive Domain score at Month 3 wasnominally greater in patients treated with EMGALITY 120 mg than in patients on placebo (21.8 for EMGALITY 120 mg vs.
16.8 for placebo; nominal p-value <0.001).
Figure 5: Change from Baseline in Monthly Migraine Headache Days in Study 3a
a Least-square means and 95% confidence intervals are presented.
Figure 6 shows the distribution of change from baseline in the mean number of monthly migraine headache days for the
3-month study period in bins of 3 days by treatment group. A treatment benefit over placebo for EMGALITY is seen
across a range of changes from baseline in monthly migraine headache days.
Figure 6: Distribution of Change from Baseline in Mean Monthly Migraine Headache Days over Months 1 to 3 byTreatment Group in Study 3
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
EMGALITY (galcanezumab-gnlm) injection is a sterile, preservative-free, clear to opalescent, colorless to slightly yellow toslightly brown solution for subcutaneous administration.
EMGALITY is not made with natural rubber latex.
EMGALITY is supplied as follows:
Pack Size NDC
Prefilled pen
120 mg/mL single-dose Carton of 1 0002-1436-11
120 mg/mL single-dose Carton of 2 0002-1436-27
Prefilled syringe
120 mg/mL single-dose Carton of 1 0002-2377-11
120 mg/mL single-dose Carton of 2 0002-2377-27
16.2 Storage and Handling
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