
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
aLeast-square (LS) means are presented.
bp<0.001 vs placebo.
ADDITIONAL INFORMATION:
Mean monthly MHD reduction was averaged over Months 1 to 3.1
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
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.

“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.