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Drug Trials Snapshots: EMGALITY

HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race and age groups. The “MORE INFO” bar shows more detailed technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.

LIMITATIONS OF THIS SNAPSHOT:
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your health provider about the risks and benefits of a drug. Refer to the EMGALITY Package Insert for complete information.

EMGALITY (galcanezumab-gnim)
Em-GAL-it-ē
Eli Lilly and Company
Approval date: September 27, 2018


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

EMGALITY is a drug used for the preventive treatment of migraine in adults.

A migraine is a type of headache that can be associated with nausea, vomiting, and sensitivity to light, sound, or smell.

How is this drug used?

EMGALITY is given by once-a-month injections under the skin (subcutaneous injections).

What are the benefits of this drug?

Patients treated with EMGALITY experienced fewer days per month with migraine headaches, in comparison to patients who received placebo treatment.

What are the benefits of this drug (results of trials used to assess efficacy)?

The figures below summarize efficacy results for the evaluated patients in Trials 1, 2, and 3. The primary outcome was the change in monthly migraine days (MMD).

Figure 4. Change from Baseline in Monthly Migraine Headache Days in Trial 1a

Figure summarizes efficacy results for clinical trial 1.

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

Figure 5. Change from Baseline in Monthly Migraine Headache Days in Trial 2a

Figure summarizes efficacy results for clinical trial 2.

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

Figure 6. Change from Baseline in Monthly Migraine Headache Days in Trial 3a

Figure summarizes efficacy results for clinical trial 3.

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

EMGALITY Prescribing Information

Were there any differences in how well the drug worked in clinical trials among sex, race and age?

  • Sex: EMGALITY worked similarly in men and women.
  • Race: The majority of patients was White. The number of patients in other races was limited; therefore, differences in how EMGALITY worked among races could not be determined.
  • Age: The majority of patients was less than 65 years of age; therefore, differences in how EMGALITY worked among age groups could not be determined.

Were there any differences in how well the drug worked in clinical trials among sex, race, and age groups?

The tables below summarize efficacy results by sex, race and age. The majority of patients was White, and the number of patients in all other races was limited. Therefore, all other races were combined. Racial subgroup differences were investigated between Whites and all other races combined.

Table 2. Trials 1 and 2 – Change from Baseline in Monthly Migraine Headache Days by Sex

Episodic Migraine Pooled Subgroup Analysis
Sex Placebo (N=875) EMGALITY (N=436)
Male
Overall n (%) 136 (15.5) 66 (15.1)
LS mean (SE) -2.76 (0.49) -3.79 (0.58)
95% CI (-3.73, -1.80) (-4.93, -2.64)
Comparison with placebo
LS mean (SE)   -1.03 (0.52)
95% CI (-2.05, -0.00)
Female
Overall n (%) 739 (84.5) 370 (84.9)
LS mean (SE) -2.55 (0.17) -4.65 (0.21)
95% CI (-2.87, -2.22) (-5.05, -4.24)
Comparison with placebo
LS mean (SE)   -2.10 (0.21)
95% CI (-2.52, -1.68)

FDA Review

Table 3. Trial 3 – Change from Baseline in Monthly Migraine Headache Days by Sex

Chronic Migraine Pooled Subgroup Analysis
Sex Placebo (N=538) EMGALITY (N=273)
Male
Overall n (%) 72 (13.38) 40 (14.65)
LS mean (SE -2.78 (1.07) -5.12 (1.35)
95% CI (-4.89, -0.67) (-7.78, -2.46)
Comparison with placebo
LS mean (SE)   -2.34 (1.21)
95% CI (-4.73, -0.05)
Female
Overall n (%) 466 (86.62) 233 (85.35)
LS mean (SE) -2.78 (0.39) -4.82 (0.46)
95% CI (-3.54, -2.02) (-5.73, -3.91)
Comparison with placebo
LS mean (SE)   -2.04 (0.45)
95% CI (-2.93, -1.15)

FDA Review

Table 4. Trials 1 and 2 – Change from Baseline in Monthly Migraine Headache Days by Race

Episodic Migraine Pooled Subgroup Analysis
Race Placebo (N=875) EMGALITY (N=436)
White
Overall n (%) 667 (76.23) 328 (75.23)
LS mean (SE -2.42 (0.18) -4.43 (0.22)
95% CI (-2.77, -2.08) (-4.86, -4.00)
Comparison with placebo
LS mean (SE)   -2.01 (0.22)
  95% CI (-2.45, -1.57)
All Other Races
Overall n (%) 208 (13.77) 108 (24.77)
LS mean (SE) -3.06 (0.40) -4.87 (0.47)
95% CI (-3.85, -2.26) (-5.79, -3.95)
Comparison with placebo
LS mean (SE)   -1.82 (0.41)
95% CI (-2.62, -1.01)

FDA Review

Table 5. Trial 3 – Change from Baseline in Monthly Migraine Headache Days by Race

Chronic Migraine Subgroup Analysis
Race Placebo (N=538) EMGALITY (N=273)
White
Overall n (%) 418 (77.70) 218 (79.85)
LS mean (SE -2.47 (0.43) -4.91 (0.51)
95% CI (-3.32, -1.63) (-5.90, --3.91)
Comparison with placebo
LS mean (SE)   -2.44 (0.47)
95% CI (-3.36, -1.51)
Other Races
Overall n (%) 120 (22.30) 55 (21.15)
LS mean (SE) -4.16 (0.92) -5.08 (1.04)
95% CI (-5.97, -2.35) (-7.13, -3.02)
Comparison with placebo
LS mean (SE)   -0.92 (0.93)
95% CI (-2.75, -0.92)

FDA Review

Table 6. Trials 1 and 2 – Change from Baseline in Monthly Migraine Headache Days by Age

Episodic Migraine Pooled Subgroup Analysis
Age Group Placebo (N=875) EMGALITY (N=436)
< 25 years
Overall n (%) 59 (6.7) 39 (8.9)
LS mean (SE -3.49 (0.49) -4.66 (0.62)
95% CI (-4.47, -2.52) (-5.89, -3.43)
Comparison with placebo
LS mean (SE)   -1.17 (0.68)
95% CI (-2.51, 0.17)
> 25 to < 45 years
Overall n (%) 440 (50.3) 214 (49.1)
LS mean (SE) -2.43 (0.22) -4.28 (0.27)
95% CI (-2.85, -2.00) (-4.80, -3.76)
Comparison with placebo
LS mean (SE)   -1.85 (0.28)
95% CI (-2.40, -1.31)
> 45 years
Overall n (%) 376 (43.0) 183 (42.0)
LS mean (SE) -2.60 (0.24) -4.86 (0.30)
95% CI (-3.07, -2.13) (-5.46, -4.26)
Comparison with placebo
LS mean (SE)   -2.26 (0.31)
95% CI (-2.87, -1.66)

FDA Review

Table 7. Trial 3 – Change from Baseline in Monthly Migraine Headache Days by Age

Chronic Migraine Subgroup Analysis
Age Group Placebo (N=538) EMGALITY (N=273)
< 25 years
Overall n (%) 50 (9.3) 32 (11.7)
LS mean (SE -2.29 (1.62) -2.88 (1.93)
95% CI (-5.51, 0.93) (-6.70, 0.94)
Comparison with placebo
LS mean (SE)   -0.59 (1.49)
95% CI (-3.55, 2.36)
> 25 to < 45 years
Overall n (%) 247 (45.9) 133 (48.7)
LS mean (SE) -3.52 (0.58) -5.50 (0.66)
95% CI (-4.66, -2.38) (-6.80, -4.19)
Comparison with placebo
LS mean (SE)   -1.98 (0.62)
95% CI (-3.19, 0.77)
> 45 years to < 65 years
Overall n (%) 241 (44.8) 108 (39.6)
LS mean (SE) -2.15 (0.51) -4.56 (0.65)
95% CI (-3.15, -1.15) (-5.83, -3.29)
Comparison with placebo
LS mean (SE)   -2.41 (0.65)
95% CI (-3.69, -1.12)

FDA Review

What are the possible side effects?

EMGALITY may cause serious hypersensitivity reactions including rash, itching, hives, and shortness of breath.

The most common side effects of EMGALITY were injection site reactions.

What are the possible side effects (results of trials used to assess safety)?

The table below summarizes adverse reactions in adult patients with chronic or episodic migraine headaches in combined trials (safety population).

Table 8. Adverse Reactions Occurring in Adults with Migraine with an Incidence of at least 2% for EMGALITY and at least 2% greater than Placebo (up to 6 Months of Treatment) in Trials 1, 2, and 3

Adverse Reaction EMGALITY 120 mg
(N=705)
%
Placebo
(N=1451)
%
Injection site reactionsa 18 13

a Injection site reactions include multiple adverse reaction related terms, such as injection site pain, injection site reaction, injection site erythema, injection site pruritus and injection site hypersensitivity.

EMGALITY Prescribing Information

Were there any differences in side effects among sex, race and age?

  • Sex: The occurrence of side effects was similar in men and women.
  • Race: The majority of patients was White. The number of patients in other races was limited; therefore, the occurrence of side effects among races could not be determined.
  • Age: The majority of patients was less than 65 years of age; therefore, differences in side effects among age groups could not be determined.

Were there any differences in side effects of the clinical trials among sex, race, and age groups?

The table below summarizes the occurrence of the most common adverse reaction, injection site reactions, by subgroup.

Table 9. Subgroup Analysis of Injection Site Reactions* (safety population)

Demographic Characteristic EMGALITY
120 mg n/N (%)
Placebo
n/N (%)
Sex
Men 11/106 (10) 22/214 (10)
Women 118/599 (20) 161/1237 (13)
Race
White 107/545 (20) 159/1112 (14)
Black or African American 5/53 (9) 10/69 (14)
Asian 9/48 (19) 5/89 (6)
Other** 8/59 (14) 9/133 (7)
Age Group
< 65 years 129/703 (18) 180/1444 (12)
> 65 years 0/2 (0) 3/7 (43)

* Includes Injection site reactions include multiple adverse reaction related terms, such as injection site pain, injection site reaction, injection site erythema, injection site pruritus and injection site hypersensitivity.
** Includes American Indian or Native Alaskan and Native Hawaiian and Other Pacific Islander.

Clinical Trial Data

WHO WAS IN THE CLINICAL TRIALS?

Who participated in the clinical trials?

The FDA approved EMGALITY based on evidence from three clinical trials (Trial 1/NCT02614183, Trial 2/NCT02614196, and Trial 3/NCT02614261) in 2156 patients with chronic or episodic migraine headaches.

Trials were conducted at 318 sites in Asia, Canada, Europe, Israel, Latin America, Puerto Rico, and the United States.

Figure 1 summarizes how many men and women were in the clinical trials.

Figure 1. Baseline Demographics by Sex

Pie chart summarizing how many men and women were in the clinical trials. In total, 320 men (15%) and 1836 (85%) women participated in the clinical trials.

FDA Review

Figure 2 summarizes the percentage of patients by race in the clinical trials.

Figure 2. Baseline Demographics by Race

Pie chart summarizing the percentage of patients by race enrolled in the clinical trials. In total, 1657 White (77%), 170 Black or African American (8%), 137 Asian (6%) and 192 Other patients (9%) participated in the clinical trials.

* Other includes American Indian or Native Alaskan, Native Hawaiian or Other Pacific Islander

Clinical Trial Data

Table 1. Demographics of Efficacy Trials by Race

Race Number of Patients Percentage of Patients
White 1657 77%
Black or African American 170 8%
Asian 137 6%
Other* 192 9%

* Other includes American Indian or Native Alaskan, Native Hawaiian or Other Pacific Islander

Clinical Trial Data

Figure 3 summarizes the percentage of patients by age in the clinical trials.

Figure 3. Baseline Demographics by Age

Pie charts summarizing how many individuals of certain age groups were enrolled in the clinical trials. In total, 2147 patients (99%) were less than 65 years old, and 9 patients (less than 1%) were 65 years and older

Clinical Trial Data

Who participated in the trials?

The tables below summarizes the demographics of the safety population.

Table 10. Baseline Demographics of the Safety Population

Demographic Characteristic EMGALITY 120 mg (N=705) PLACEBO
(N=1451)
TOTAL
(N=2156)
Sex
Men 106 (15.0) 214 (14.8) 320 (14.8)
Women 599 (85.0) 1237 (85.2) 1836 (85.2)
Race
White 545 (77.3) 1112 (76.6) 1657 (76.9)
Black or African American 53 (7.5) 117 (8.1) 170 (7.9)
Asian 48 (6.8) 89 (6.1) 137 (6.4)
American Indian or Native Alaskan 10 (1.4) 24 (1.7) 34 (1.6)
Native Hawaiian or Other Pacific Islander 0 (0) 2 (< 1) 2 (< 1)
Other 49 (7.0) 107 (7.4) 156 (6.8)
Age
< 25 years 68 (9.6) 117 (8.1) 185 (8.6)
25 to < 30 years 71 (10.1) 152 (10.5) 223 (10.3)
30 to < 50 years 381 (54.0) 777 (53.5) 1158 (53.7)
> 50 to 64 years 183 (26.0) 398 (27.4) 581 (26.9)
> 65 years 2 (< 1) 7 (< 1) 9 (< 1)
Ethnicity
Hispanic 149 (21.1) 298 (20.5) 447 (20.7)
Not Hispanic 522 (74.0) 1077 (74.2) 1599 (74.2)
Not Reported 34 (4.8) 76 (5.2) 110 (5.1)
Region
Canada 24 (3.4) 52 (3.5) 76 (3.5)
Europe 126 (17.9) 262 (18.1) 388 (18.0)
Puerto Rico 8 (1.1) 24 (1.7) 32 (1.5)
United States 440 (62.4) 901 (62.1) 1341 (62.2)
Other 107 (15.2) 212 (14.6) 319 (14.8)

Clinical Trial Data

How were the trials designed?

The benefit and side effects of EMGALITY were evaluated in three clinical trials in adult patients 18 to 65 years of age with a history of migraine headaches.

Trials 1 and 2 enrolled patients with a history of episodic migraine headaches. Patients were assigned to receive EMGALITY or placebo injections once a month for 6 months. Neither the patients nor the health care providers knew which treatment was being given until after the trial was completed. The benefit of EMGALITY was assessed based on the change from baseline in the number of migraine days per month during the 6-month treatment period, comparing patients in the EMGALITY and placebo groups.

Trial 3 enrolled patients with a history of chronic migraine headaches. Patients were assigned to receive EMGALITY or placebo injection once a month for 3 months. Neither the patients nor the health care providers knew which treatment was being given until after the trial was completed. The benefit of EMGALITY was assessed based on the change from baseline in the number of migraine days per month during the 3-month treatment period, comparing the EMGALITY and placebo groups.

How were the trials designed?

The efficacy and safety of EMGALITY were evaluated in three clinical trials.

Trials 1 and 2 were randomized, placebo controlled, double blind, 6-month trials evaluating EMGALITY for the preventive treatment of episodic migraine in adult patients with a history of up to 14 migraine headache days per month. Patients were randomized to receive EMGALITY 120 mg or placebo once a month for 6 months. Patients randomized to EMGALITY 120 mg monthly received an initial dose of 240 mg on the first month, followed by monthly injections of 120 mg. Patients could use acute headache treatments. The primary efficacy endpoint was the change from baseline in the monthly average number of migraine days (MMD) during the 6-month treatment period.

Trial 3 was a randomized, placebo controlled, double blind, 3-month trial evaluating EMGALITY for the preventive treatment of chronic migraine in adult patients with a history of at least 15 headache days per month, with 8 or more migraine days per month. Patients were randomized to receive EMGALITY 120 mg or placebo once a month for 3 months. Patients randomized to EMGALITY 120 mg monthly received an initial dose of 240 mg on the first month, followed by monthly injections of EMGALITY 120 mg. Patients could use acute headache treatments, and up to one third of patients could use one other preventive treatment for migraine during the trial. The primary efficacy endpoint was the change from baseline in the MMD during the 3-month treatment period.

GLOSSARY

CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.

PRESCRIBING INFORMATION

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