^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.

Review study design for REGAIN
See data for episodic migraine

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 dose^1,3

Difference from placebo observed at Month 1^1,3

Graph of change from baseline in monthly MHDs

^cLS means and 95% confidence intervals are presented.

^dEarliest post-baseline, prespecified assessment.

Review study design for REGAIN
See data for episodic migraine

“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.

With Emgality, a significantly greater mean percentage of patients achieved a ≥50% reduction in monthly migraine headache days (MHDs) from baseline vs placebo¹

Graph of greater than or equal to 50% reduction of monthly MHDs

^ap<0.001 vs placebo.

KEY HIGHLIGHT:

28% of patients taking Emgality achieved a ≥50% reduction in monthly MHDs from baseline vs 15% with placebo.¹

Review study design for REGAIN
See data in episodic migraine

In REGAIN, Emgality 120 mg was not significantly better than placebo for the mean percentage of patients with ≥75% or 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 mean change in Migraine-Specific Quality of Life version 2.1 (MSQ v2.1) Role-Function Restrictive (RF-R) or for reduction in mean MHDs with acute medication use.¹

“I used to have over 20 migraine days per month and now that number has been significantly reduced.”

— Ashley, a patient with chronic migraine

Watch Ashley’s story here.

^bPatients were compensated for their time.

SELECT IMPORTANT SAFETY INFORMATION
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.

Mean change in monthly migraine headache days (MHDs) in patients with ≥2 prior preventive failures⁴

Graph of subgroup analysis of mean change from baseline in monthly MHDs in patients who failed 2+ preventive treatments

Post hoc analysis of REGAIN. The REGAIN study was neither adequately powered nor error-controlled for subgroup analyses. Treatment differences observed in this subgroup cannot be regarded as statistically significant. Patients were excluded from the study if they had failed to respond to 3 or more adequately dosed (that is, maximum tolerated dose for at least 2 months) migraine preventive treatments from different classes. Failure to respond due to tolerability issues was not considered an exclusion criterion. Migraine preventive treatments are defined as Level A and Level B of the American Academy of Neurology’s Evidence-based Guideline Update: Pharmacologic Treatment for Episodic Migraine Prevention in Adults, as well as botulinum toxin A or B. Assignment to the subgroup of patients who failed <2 or failed ≥2 individual preventive medications was based on patient report of previous discontinuation of a migraine preventive due to lack of efficacy, suboptimal efficacy, or intolerability.⁵

Review study design for REGAIN
See data for episodic migraine

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.

Change in mean monthly MHDs in patients with or without baseline acute medication overuse^6c

Graph of mean change from baseline in number of monthly MHDs in patients with or without baseline acute medication overuse

^cMedication overuse was defined as exceeding the following thresholds for total days of use of any of the following drug classes (or medications containing drugs from these classes) per 30-day period of the prospective baseline period as reported in an electronic diary⁷:

Any triptan for ≥10 days
Any nonsteroidal anti-inflammatory drug (NSAID) or aspirin for ≥15 days
Any acetaminophen/paracetamol for ≥15 days
Any ergot or ergotamine derivative for ≥10 days
Any combination drugs containing 2 or more of the above medication classes for ≥10 days
Total days with drug use from at least 2 of the above categories for ≥10 days

Post hoc repeated measures subgroup analysis of REGAIN data. As this analysis was post hoc, treatment differences observed in this subgroup cannot be regarded as statistically significant. Patients were excluded from the study if they used opioids or barbiturate-containing analgesics >3 times per month for the treatment of pain in more than 2 of the 6 months prior to the study.

Review study design for REGAIN
See data for episodic migraine

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

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 trial^1,8

REGAIN was a 3-month, randomized, multicenter, double-blind, placebo-controlled study conducted in the United States and 11 other countries^1,8

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 endpoints^1,2

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 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.^1,9

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.

Ask Lilly your questions!
We’re here to help.

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

ADDITIONAL INFORMATION:

KEY HIGHLIGHT:

Emgality makes a difference after the first dose^1,3

Difference from placebo observed at Month 1^1,3

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

— Leia, a patient with chronic migraine

With Emgality, a significantly greater mean percentage of patients achieved a ≥50% reduction in monthly migraine headache days (MHDs) from baseline vs placebo¹

KEY HIGHLIGHT:

“I used to have over 20 migraine days per month and now that number has been significantly reduced.”

— Ashley, a patient with chronic migraine

Mean change in monthly migraine headache days (MHDs) in patients with ≥2 prior preventive failures⁴

Change in mean monthly MHDs in patients with or without baseline acute medication overuse^6c

“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 trial^1,8

Indications

Important Safety Information

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

ADDITIONAL INFORMATION:

KEY HIGHLIGHT:

Emgality makes a difference after the first dose1,3

Difference from placebo observed at Month 11,3

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

— Leia, a patient with chronic migraine

“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

Indications

Important Safety Information

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You are now leaving Emgality.com.

Are you a US healthcare provider?

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

Emgality makes a difference after the first dose^1,3

Difference from placebo observed at Month 1^1,3

Emgality was studied as a preventive treatment for chronic migraine in a Phase 3 trial^1,8