Discover what Emgality can do for patients with chronic migraine¹

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

Emgality was studied as a preventive treatment for chronic migraine in a Phase 3 trial^1,3

REGAIN was a 3-month, randomized, multicenter, double-blind, placebo-controlled study conducted in the United States and 11 other countries^1,3

Adult patient population (N=1113)^1,3

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

Prespecified key endpoints^1,4

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 3^a
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.^1,5

Review study design for EVOLVE-1 and EVOLVE-2

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.

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

Review safety profile or the results from the 12-month, open-label safety study for Emgality

References:

Emgality [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC.
Data on File. Lilly USA, LLC. DOF-GZ-US-0002.
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.
Data on File. Lilly USA, LLC. DOF-GZ-US-0120.
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.

IMPORTANT SAFETY INFORMATION

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

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.

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 14SEP2022

INDICATIONS

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

Preventive treatment of migraine
Treatment of episodic cluster headache

Discover what Emgality can do for patients with chronic migraine¹

Meet a patient with chronic migraine^a

Primary Endpoint Result

Secondary Endpoint Result

Emgality was studied as a preventive treatment for chronic migraine in a Phase 3 trial^1,3

IMPORTANT SAFETY INFORMATION

INDICATIONS

Discover what Emgality can do for patients with chronic migraine1

Meet a patient with chronic migrainea

Primary Endpoint Result

Secondary Endpoint Result

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

IMPORTANT SAFETY INFORMATION

INDICATIONS

Discover what Emgality can do for patients with chronic migraine¹

Meet a patient with chronic migraine^a

Emgality was studied as a preventive treatment for chronic migraine in a Phase 3 trial^1,3