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

Get eligible patients started today with the Emgality savings card


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