Meet Jessica, a patient with episodic migraine

aHypothetical patient profile.

For your patients with 4-14 migraine headache days (MHDs) per month,

More is possible for patients like Jessica1

For your patients with 4-14 MHDs per month,1


Emgality delivered significantly more migraine-free days vs placebo1

Graph of mean reduction in monthly MHDs

aLeast-square (LS) means are presented.

bp<0.001 vs placebo.


A migraine-free day is everything to me. It’s a day that I can be me. I can be a mom. I can be a wife. I can be a friend.

— Lisa, a patient with episodic migraine

Watch Lisa’s story here.

cPatients were compensated for their time.


SELECT IMPORTANT SAFETY INFORMATION
Contraindications
Emgality is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients.

Emgality makes a difference after the first dose1,3

Difference from placebo observed at Month 11,3

Graphs of change from baseline in monthly MHDs

dLS means and 95% confidence intervals are presented.

eEarliest post-baseline, prespecified assessment.

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

  • EVOLVE-1: -4.0 mean MHDs per month with Emgality 120 mg (N=210) vs -2.2 mean MHDs per month with placebo (N=425)
  • EVOLVE-2: -3.7 mean MHDs per month with Emgality 120 mg (N=226) vs -1.9 mean MHDs per month with placebo (N=450)



Emgality was studied as a preventive treatment for episodic migraine in two Phase 3 trials1,18,19

EVOLVE-1 (North America) and EVOLVE-2 (Global) were 6-month, randomized, multicenter, double-blind, placebo-controlled studies in patients with episodic migraine1,18,19

Patient population (N=1773)1,18,19

  • Patients with 4-14 MHDs per month
  • Migraine was defined as:
    • Headache with or without aura
    • Lasting 30 minutes or more
    • Meeting International Classification of Headache Disorders-3 beta (ICHD-3 beta) criteria for diagnosis

Exclusion criteria1

  • Patients on any other migraine preventive treatment
  • Patients with medication overuse headache
  • Patients with electrocardiogram (ECG) abnormalities compatible with an acute cardiovascular event
  • Patients with a history of stroke, myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass grafting, deep vein thrombosis, or pulmonary embolism within 6 months of screenings

6-month treatment period1

  • Participants were randomized to once-monthly placebo, Emgality 120 mg after an initial loading dose of 240 mg, or Emgality 240 mg. 240 mg is an unapproved dose
  • Acute treatments for headache, including migraine-specific medications (ie, triptans, ergotamine derivatives), nonsteroidal anti-inflammatory drugs (NSAIDs), and acetaminophen were allowed

Prespecified key endpoints1,2

  • Primary endpoint: Least-square (LS) mean change from baseline in the number of monthly MHDs over Months 1 to 6
  • Secondary endpoint: Mean percentage of patients with ≥50%, ≥75%, and 100% reduction from baseline in the number of monthly MHDs over Months 1 to 6

Additional key secondary endpoints1

  • Impact of migraine on daily activities, as assessed by the mean change from baseline in the average Migraine-Specific Quality of Life version 2.1 (MSQ v2.1) Role Function-Restrictive (RF-R) domain score over Months 4 to 6b
  • Mean change from baseline in the number of monthly MHDs with use of any acute medication for headache during the 6-month treatment period

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.1,8

Review study design for REGAIN

Review the safety profile of Emgality


References: 1. Emgality [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC. 2. Data on File. Lilly USA, LLC. DOF-GZ-US-0120. 3. Data on File. Lilly USA, LLC. DOF-GZ-US-0002. 4. Aimovig [Prescribing Information]. Thousand Oaks, CA: Amgen Inc.; 2019. 5. Ajovy [Prescribing Information]. North Wales, PA: Teva Pharmaceuticals USA, Inc.; 2019. 6. Data on File. Lilly USA, LLC. DOF-GZ-US-0010. 7. Data on File. Lilly USA, LLC. DOF-GZ-US-0012. 8. 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. 9. Data on File. Lilly USA, LLC. DOF-GZ-US-0025. 10. Data on File. Lilly USA, LLC. DOF-GZ-US-0015. 11. Data on File. Lilly USA, LLC. DOF-GZ-US-0016. 12. 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. 13. Data on File. Lilly USA, LLC. DOF-GZ-US-0092. 14. Data on File. Lilly USA, LLC. DOF-GZ-US-0091. 15. Data on File. Lilly USA, LLC. DOF-GZ-US-0090. 16. Data on File. Lilly USA, LLC. DOF-GZ-US-0084. 17. Data on File. Lilly USA, LLC. DOF-GZ-US-0024. 18. Stauffer VL, Dodick DW, Zhang Q, et al. Evaluation of galcanezumab for the prevention of episodic migraine: the EVOLVE-1 randomized clinical trial. JAMA Neurol. 2018;75(9):1080-1088. 19. 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;38(8):1442-1454.

Indications and Important Safety Information
Indications

Emgality is a calcitonin gene-related peptide (CGRP) antagonist indicated in adults for the:

  • Preventive treatment of migraine
  • Treatment of episodic cluster headache

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, including dyspnea, urticaria, and rash, have occurred with Emgality in clinical studies and the postmarketing setting. Cases of anaphylaxis and angioedema have also been reported in the postmarketing setting. 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.


Please see Full Prescribing Information, including Patient Information, for Emgality. See Instructions for Use included with the device.


GZ HCP ISI 10DEC2019