Meet a patient with chronic migraine

aHypothetical patient profile.

For your patients with ≥15 headache days per month,

Discover what’s possible for patients with chronic migraine1



For your patients with ≥15 headache days per month,1


Emgality made it possible to have nearly 5 fewer migraine headache days (MHDs) per month on average1

Graph of mean reduction in monthly MHDs

aLeast-square (LS) means are presented.

bp<0.001 vs placebo.

Additional Emgality information icon

ADDITIONAL INFORMATION:

Mean monthly MHD reduction was averaged over Months 1 to 3.1

Key Emgality highlight lightbulb icon

KEY HIGHLIGHT:

Patients had 4.8 fewer MHDs from baseline with Emgality vs 2.7 MHDs with placebo.1


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

Graph of change from baseline in monthly MHDs

cLS means and 95% confidence intervals are presented.

dEarliest post-baseline, prespecified assessment.


Not having all those migraines means I get to spend more time playing with my kids.

— Leia, a patient with chronic migraine

Watch Leia’s story here.

ePatients were compensated for their time.


Mom in tiara and daughter in crown reading a book in Emgality bubble

Having chronic migraine means that at least half my month will be headache days. I need a preventive treatment so I can try to be with my family as much as possible.

— Hypothetical patient with chronic migraine



Emgality was studied as a preventive treatment for chronic migraine in a Phase 3 trial1,8

REGAIN was a 3-month, randomized, multicenter, double-blind, placebo-controlled study conducted in the United States and 11 other countries1,8

Patient population (N=1113)1,8

  • Patients with ≥15 headache days per month, at least 8 of which had the feature of migraine
  • Migraine was defined as:
    • Lasting 30 minutes or more
    • Meeting International Classification of Headache Disorders-3 beta (ICHD-3 beta) criteria for diagnosis
  • Patients with medication overuse headache were allowed to enroll

Exclusion criteria1

  • 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 screening

3-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 drug (NSAIDs), and acetaminophen were allowed
    • 15% of patients continued 1 concomitant preventive treatment

Prespecified key endpoints1,2

  • Primary endpoint: Least-square (LS) mean change from baseline in the number of monthly MHDs over Months 1 to 3
  • Secondary endpoint: Mean percentage of patients with ≥50%, ≥75%, and 100% reduction from baseline in the number of monthly MHDs over Months 1 to 3

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 at Month 3a
  • Mean change from baseline in the number of monthly MHDs with use of any acute medication for headache during the 3-month treatment period

aMSQ 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.1,9

Review study design for EVOLVE-1 and EVOLVE-2
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. Data on File. Lilly USA, LLC. DOF-GZ-US-0063. 5. 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. 6. Data on File. Lilly USA, LLC. DOF-GZ-US-0057. 7. Data on File. Lilly USA, LLC. DOF-GZ-US-0024. 8. Detke HC, Goadsby PJ, Wang S, et al. Galcanezumab in chronic migraine: the randomized, double-blind, placebo-controlled REGAIN study. Neurology. 2018;91(24):e2211-e2221. 9. 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.

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