Discover what Emgality^® can do for patients with episodic migraine¹

Primary Endpoint Result

Emgality delivered significantly more migraine-free days vs placebo¹

Emgality helps prevent migraine days before they start¹

Review study design for EVOLVE-1 and EVOLVE-2
See data for chronic migraine or the 12-month, open-label safety study

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

Emgality reduced mean monthly MHDs in every month of the 6-month treatment period^1,3

MHD reductions occurred in the first month and every following month^1,3

No formal hypothesis testing was conducted to evaluate treatment difference in mean monthly MHD reduction at each month. However, patients treated with Emgality 120mg showed a nominally greater reduction in number of monthly MHDs at each month compared to placebo.^1,3

Review study design for EVOLVE-1 and EVOLVE-2
See data for chronic migraine or the 12-month, open-label safety study

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)

Secondary Endpoint Result

Emgality demonstrated ≥50%, ≥75%, and 100% reductions in monthly MHDs from baseline for a significantly greater mean percentage of patients vs placebo¹

First and only CGRP antibody approved by the FDA that delivered a month of total migraine freedom to a significantly greater mean percentage of patients across two Phase 3 trials vs placebo^1,4-8

Review study design for EVOLVE-1 and EVOLVE-2
See data for chronic migraine or the 12-month, open-label safety study

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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.

For patients with 4-14 MHDs per month,

A greater mean percentage of patients on Emgality achieved a ≥50% reduction in monthly MHDs vs placebo¹

No formal hypothesis testing was conducted to evaluate treatment differences observed at each month of the treatment period. Values should not be considered statistically significant.

Review study design for EVOLVE-1 and EVOLVE-2
See data for chronic migraine

Secondary Endpoint Result

≥50% reduction of mean monthly MHDs for Months 1 to 3 and Months 4 to 6¹¹

Post hoc analysis of EVOLVE-1 and EVOLVE-2. No conclusions of statistical or clinical significance can be drawn. The mean monthly percentage of patients meeting response criteria during Months 1 to 3 and Months 4 to 6 of the double-blind treatment phase was estimated using generalized linear repeated measures models.

Review study design for EVOLVE-1 and EVOLVE-2
See data for chronic migraine

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Adverse Reactions
The most common adverse reactions (incidence ≥2% and at least 2% greater than placebo) in Emgality clinical studies were injection site reactions.

100% reduction of monthly MHDs in at least 1, 2, or 3 months¹²

Post hoc analyses of EVOLVE-1 and EVOLVE-2 pooled data. Results reported are simple calculations of percentages. As these analyses are post hoc, no conclusions of statistical or clinical significance can be drawn.

Review study design for EVOLVE-1 and EVOLVE-2
See data for chronic migraine

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

Emgality significantly reduced the impact of migraine on daily activities¹

Patients treated with Emgality were less impacted by migraine during daily activities¹

Migraine-Specific Quality of Life (MSQ) v2.1 scores are scaled from 0 to 100. Higher scores indicate less impact of migraine on daily activities.¹

On the MSQ v2.1 RF-R, Emgality demonstrated a mean improvement from baseline vs placebo over Months 4 to 6.¹

For your patients with ≥ 15 headache days per month, Emgality 120 mg was not statistically different from placebo for mean change in MSQ RF-R over the 3-month treatment period, after controlling for multiple comparisons.¹

Review study design for EVOLVE-1 and EVOLVE-2

Patients completed the Role Function-Restrictive (RF-R) domain of the MSQ v2.1, a functional impact tool^1,13

MSQ v2.1 is a self-administered tool developed to assess the impact of migraine on patients’ health-related quality of life.^1,13

What does the MSQ v2.1 RF-R measure?^1,13

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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.

Migraine study designs^1,2

EVOLVE-1 and EVOLVE-2 were 6-month, double-blind, placebo-controlled studies that enrolled adult patients with episodic migraine (defined as 4-14 migraine headache days per month) (N=1773). REGAIN was a 3-month, double-blind, placebo-controlled study that enrolled adult patients with chronic migraine (defined as ≥15 headache days per month with ≥8 migraine days per month) (N=1113). In all 3 studies, patients were randomized to receive once monthly placebo, Emgality 120 mg after an initial loading dose of 240 mg, or Emgality 240 mg. 240 mg is an unapproved dose. In EVOLVE-1 and EVOLVE-2, other treatments for migraine prevention were not allowed. In REGAIN, a subset of patients (15%) continued 1 concomitant migraine preventive medication. In all 3 studies, patients were allowed to use acute treatments for headache, including migraine-specific medications (ie, triptans, ergotamine derivatives), NSAIDs, and acetaminophen during the study. For each study, the primary endpoint was the LS mean change from baseline in the number of monthly MHDs over the double-blind treatment period in the intent-to-treat population.

Exclusion criteria¹

EVOLVE-1, EVOLVE-2, and REGAIN excluded patients with electrocardiogram abnormalities compatible with an acute cardiovascular event and 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. EVOLVE-1 and EVOLVE-2 also excluded patients with medication overuse headache.

Secondary Endpoint Result

≥50% response rates in patients with varying levels of prior preventive exposure^14-16

Post hoc analysis of EVOLVE-1 and EVOLVE-2 pooled data. The EVOLVE-1 and EVOLVE-2 pooled data were neither adequately powered nor error-controlled for subgroup analyses. Treatment differences observed in these subgroups 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 were naïve, failed ≥1, and 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.¹⁷

Review study design for EVOLVE-1 and EVOLVE-2
See data for chronic migraine

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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 monthly MHDs in patients with or without baseline acute medication overuse^18,19a

19% of patients in both the EVOLVE-1 and EVOLVE-2 studies overused acute medication at baseline^20,21

^aMedication 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 diary²²:

• 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 EVOLVE-1 and EVOLVE-2 data. As this analysis was post hoc, treatment differences observed in these subgroups cannot be regarded as statistically significant. Patients were excluded from the studies if they used opioids or barbiturate-containing analgesics >2 times per month for the treatment of pain in more than 2 of the 6 months prior to the study. The studies excluded patients with a diagnosis of medication overuse headache in the preceding 3 months.¹⁷

Review study design for EVOLVE-1 and EVOLVE-2
See data for chronic migraine

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

Emgality was studied as a preventive treatment for episodic migraine in two Phase 3 trials^1,4,5

EVOLVE-1 (North America) and EVOLVE-2 (Global) were 6-month, randomized, multicenter, double-blind, placebo-controlled studies in patients with episodic migraine^1,4,5

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

Adult patient population (N=1773)^1,4,5

• 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 endpoints^1,2

• 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 6^a
• Mean change from baseline in the number of monthly MHDs with use of any acute medication for headache during the 6-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.^1,8

Review study design for REGAIN

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.