Efficacy


Episodic study design

The efficacy and safety of Emgality were evaluated in two large Phase 3 trials1-3

EVOLVE-1 (Study 1; North America) and EVOLVE-2 (Study 2; Global) were 6-month, randomized, multicenter, double-blind, placebo-controlled trials in patients with episodic migraine1-3

Emgality patient study design

a240 mg is an unapproved dose.1

bThe impact of migraine on daily activities was assessed using the Role Function-Restrictive domain of the Migraine-Specific Quality of Life Questionnaire version 2.1. MSQ v2.1 is a self-administered tool developed to assess the impact of migraine on patients’ health-related quality of life. Areas measured included: relationships with family and friends, leisure time, productivity, concentration, energy, and tiredness. Scores are scaled from 0 to 100, with higher scores indicating less impact of migraine on daily activities.1,7,8

For people with 4-14 MHDs per month,

Emgality delivered significantly more migraine-free days vs placebo1

Emgality prevented up to 4.7 mean MHDs per month vs up to 2.8 mean MHDs with placebo, on average (p<0.001)1

Change from baseline in mean monthly MHDs1,9b

Emgality mhd reduction

bLeast-square means and 95% confidence intervals are presented.
cEarliest post-baseline, prespecified assessment.

EVOLVE-1: -3.7 mean MHDs with Emgality in the first month, on average vs -1.7 mean MHDs with placebo

EVOLVE-2: -3.9 mean MHDs with Emgality in the fi rst month, on average vs -1.2 mean MHDs with placebo

Emgality significantly reduced the mean number of monthly MHDs that acute medication was used over Months 1 to 6 (p<0.001)1,10,11

  • EVOLVE-1: -4.0 MHDs per month with Emgality vs -2.2 MHDs per month with placebo
  • EVOLVE-2: -3.7 MHDs per month with Emgality vs -1.9 MHDs per month with placebo

See study design for EVOLVE-1 and EVOLVE-2

SELECT IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS

Emgality is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients.

Emgality demonstrated significant response rates in the reduction of mean monthly MHDs in any given month vs placebo1

Emgality response rates chart

ap<0.001 vs placebo.


Up to 62% of patients had a ≥50% reduction of monthly MHDs in any given month, on average (p<0.001)1

Up to 39% of patients achieved a ≥75% reduction of monthly MHDs in any given month, on average (p<0.001)1

Up to 1 in 7 patients (16%) were 100% migraine headache-free in any given month, on average (p<0.001)1


See study design for EVOLVE-1 and EVOLVE-2

100% reduction of monthly MHDs in at least 1, 2, or 3 months12

Emgality response rates

Post-hoc analyses of EVOLVE-1 and EVOLVE-2 pooled data. Results reported are simple calculations of percentages. As these analyses are post hoc, no conclusions of statistical or clinical significance can be drawn.

See study design for EVOLVE-1 and EVOLVE-2

≥50% reduction of monthly MHDs in preventive naïve and prior preventive failures13-15

Emgality test response rate

Post-hoc analysis of EVOLVE-1 and EVOLVE-2 pooled data. The studies were not adequately powered nor error-controlled for subgroup analyses. Treatment differences observed in these subgroups cannot be regarded as statistically significant. Patients were excluded from the studies if they had previously failed to have an efficacy response to ≥3 classes of migraine preventive treatments with Level A or B efficacy according to the American Academy of Neurology’s Evidence-based Guideline Update: Pharmacologic Treatment for Episodic Migraine Prevention in Adults as well as botulinum toxin A or B. Assignment to the subgroup of patients who were naïve, failed >1, and failed ≥2 preventives was based on patient report of previous discontinuation of a migraine preventive due to lack of efficacy, suboptimal efficacy, or intolerability.16

See study design for EVOLVE-1 and EVOLVE-2

SELECT IMPORTANT SAFETY INFORMATION
Hypersensitivity Reactions

Hypersensitivity reactions (e.g., rash, urticaria, and dyspnea) have been reported with Emgality in clinical studies. If a serious or severe hypersensitivity reaction occurs, discontinue administration of Emgality and initiate appropriate therapy. Hypersensitivity reactions can occur days after administration and may be prolonged.

Emgality reduced the impact on daily activities and severity of migraine1

Emgality significantly reduced the impact of migraine on daily activities over Months 4 to 6 (p<0.001), as assessed by a validated functional impact tool.1,7,8

The impact of migraine on daily activities was assessed using the Role Function-Restrictive domain of the MSQ v2.1. MSQ v2.1 is a self-administered tool developed to assess the impact of migraine on patients’ health-related quality of life.1,7,8

  • Areas measured included relationships with family and friends, leisure time, productivity, concentration, energy, and tiredness8
  • Scores are scaled from 0 to 100, with higher scores indicating less impact of migraine on daily activities1
Emgality mean improvement
  • In EVOLVE-1, Emgality demonstrated a mean improvement of 32.4 points from baseline (N=189) vs 24.7 points with placebo (N=377) over Months 4 to 6 (baseline: 51.5 points vs 52.9 points) (p<0.001)1
Emgality improvement over placebo
  • In EVOLVE-2, Emgality demonstrated a mean improvement of 28.5 points from baseline (N=213) vs 19.7 points with placebo (N=396) over Months 4 to 6 (baseline: 51.7 points vs 51.4 points) (p<0.001)1

Emgality significantly improved patients’ impression of the severity of their disease vs placebo, on average over Months 4 to 6 (p=0.002)6

  • EVOLVE-1: Mean change from baseline in PGI-S score was -1.59 for Emgality vs -1.27 for placeboa
  • EVOLVE-2: Mean change from baseline in PGI-S score was -1.22 for Emgality vs -0.94 for placeboa

aEVOLVE-1: Emgality 120 mg (N=189), placebo (N=377); EVOLVE-2: Emgality 120 mg (N=213), placebo (N=396).

SELECT IMPORTANT SAFETY INFORMATION
ADVERSE REACTIONS

The most common adverse reactions (incidence ≥2% and at least 2% greater than placebo) in Emgality clinical studies were injection site reactions.

The efficacy and safety of Emgality were evaluated in chronic migraine in a Phase 3 trial1,17

REGAIN (Study 3) was a 3-month, randomized, multicenter, double-blind, placebo-controlled trial conducted in the US and 11 other countries1,17

Emgality chronic study phase 3 trial

a240 mg is an unapproved dose.1

bMSQ v2.1 is a self-administered tool developed to assess the impact of migraine on patients’ health-related quality of life. Areas measured included: relationships with family and friends, leisure time, productivity, concentration, energy, and tiredness. Scores are scaled from 0 to 100, with higher scores indicating less impact of migraine on daily activities.1,7,8

For people with 15 or more headache days per month,

Emgality demonstrated an average reduction of 4.8 mean MHDs per month1

Emgality demonstrated an average reduction of 4.8 mean MHDs per month vs 2.7 mean MHDs per month with placebo (baseline mean: 19.4 MHDs per month vs 19.6 MHDs per month) (p<0.001)1

Emgality mean reduction

cp<0.001 vs placebo.

See study design for REGAIN

Change from baseline in mean monthly MHDs1,9de

-4.1 mean MHDs with Emgality in the first month, on average vs -1.8 mean MHDs with placebo9

Emgality change in baseline

dLeast-square means and 95% confidence intervals are presented.
eEarliest post-baseline, prespecified assessment.

See study design for REGAIN

Additional Secondary Endpoints for REGAIN Trial1

≥50% reduction of monthly MHDs was 28% with Emgality vs 15% with placebo (p<0.001)1

In REGAIN, Emgality 120 mg was not significantly better than placebo for the proportion of patients with 75% and 100% reduction from baseline in the number of monthly MHDs over the 3-month treatment period. Statistical significance vs placebo was not observed after controlling for multiple comparisons for MSQ and MHDs with acute medication use.

See study design for REGAIN

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References:

1. Emgality [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC.

2. Stauffer V, Dodick DW, Zhang Q, et al. Evaluation of galcanezumab for the prevention of episodic migraine: the EVOLVE-1 randomized clinical trial. JAMA Neurol. 2018:E1-E10. doi:10.1001/jamaneurol.2018.1212.

3. Skljarevski V, Matharu M, Millen BA, et al. Efficacy and safety of galcanezumab for the prevention of episodic migraine: results of the EVOLVE-2 Phase 3 randomized controlled clinical trial. Cephalalgia. 2018;0(0):1-13.

4. Data on File. Lilly USA, LLC. DOF-GZ-US-0022.

5. Data on File. Lilly USA, LLC. DOF-GZ-US-0023.

6. Data on File. Lilly USA, LLC. DOF-GZ-US-0001.

7. Bagley CL, Rendas-Baum R, Maglinte GA, et al. Validating Migraine-Specific Quality of Life Questionnaire v2.1 in episodic and chronic migraine. Headache. 2012;52:409-421.

8. Data on File. Lilly USA, LLC. DOF-GZ-US-0048.

9. Data on File. Lilly USA, LLC. DOF-GZ-US-0002.

10. Data on File. Lilly USA, LLC. DOF-GZ-US-0017.

11. Data on File. Lilly USA, LLC. DOF-GZ-US-0018.

12. Data on File. Lilly USA, LLC. DOF-GZ-US-0010.

13. Data on File. Lilly USA, LLC. DOF-GZ-US-0025.

14. Data on File. Lilly USA, LLC. DOF-GZ-US-0015.

15. Data on File. Lilly USA, LLC. DOF-GZ-US-0016.

16. Silberstein SD, Holland S, Freitag F, et al. Evidence-based guideline update: Pharmacologic treatment for episodic migraine prevention in adults. Neurology. 2012;78:1337-1345.

17. Data on File. Lilly USA, LLC. DOF-GZ-US-0019.

18. Data on File. Lilly USA, LLC. DOF-GZ-US-0051.

Indications and Important Safety Information
Indications

Emgality is a calcitonin gene-related peptide (CGRP) antagonist indicated for the preventive treatment of migraine in adults.

Important Safety Information

CONTRAINDICATIONS
Emgality is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients.


WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions
Hypersensitivity reactions (e.g., rash, urticaria, and dyspnea) have been reported with Emgality in clinical studies. If a serious or severe hypersensitivity reaction occurs, discontinue administration of Emgality and initiate appropriate therapy. Hypersensitivity reactions can occur days after administration and may be prolonged.


ADVERSE REACTIONS
The most common adverse reactions (incidence ≥2% and at least 2% greater than placebo) in Emgality clinical studies were injection site reactions.


Emgality is available by prescription only.


Please see Full Prescribing Information, including Patient Information for Emgality. See Instructions for Use included with the pen and prefilled syringe.


GZ HCP ISI 27SEP2018