Discover what Emgality® can do for patients with episodic migraine1
For your patients with 4-14 MHDs per month,1
Meet Jessicaa
AGE: 38
CLINICAL FACTORS
- 4 or more unpredictable migraine headache days (MHDs) per month
- Has tried therapeutic doses of 2 standard-of care generic preventives
- May now be only relying on her acute treatments
NON-CLINICAL FACTORS
- Isn’t sure another preventive will give her the results she is looking for
aHypothetical patient profile.
Even though I try to stay positive and push through, migraine continues to impact my work and my personal life. It’s important to me to find a treatment regimen that fits into my life because my family depends on me.
— Jessica, hypothetical patient with episodic migraine
Primary Endpoint Result
Emgality delivered significantly more migraine-free days vs placebo1
Emgality helps prevent migraine days before they start1
aLeast-square (LS) means are presented.
bp<0.001 vs placebo.
Review study design for EVOLVE-1 and EVOLVE-2
See data for chronic migraine or the 12-month, open-label safety study
A migraine-free day is everything to me. It’s a day that I can be me. I can be a mom. I can be a wife. I can be a friend.
— Lisa, a patient with episodic migraine
Watch Lisa’s storycPatients were compensated for their time.
SELECT IMPORTANT SAFETY INFORMATION
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 period1,3
MHD reductions occurred in the first month and every following month1,3
dLS means and 95% confidence intervals are presented.
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
Acute medications that were allowed in this study included triptans, ergotamine derivatives, NSAIDs (nonsteroidal anti-inflammatory drugs), and acetaminophen.1
In REGAIN, statistical significance vs placebo was not observed after controlling for multiple comparisons for reduction in mean MHDs with acute medication use.1
Review study design for EVOLVE-1 and EVOLVE-2
See data for chronic migraine or the 12-month, open-label safety study
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.
Secondary Endpoint Result
Emgality significantly reduced the mean number of monthly MHDs that acute medication was used vs placebo over Months 1 to 6 (p<0.001)1,23-25
- EVOLVE-1: -4.0 MHDs per month with Emgality vs -2.2 MHDs per month with placebo (baseline mean: 7.4 vs 7.4 MHDs per month)
- EVOLVE-2: -3.7 MHDs per month with Emgality vs -1.9 MHDs per month with placebo (baseline mean: 7.5 vs 7.6 MHDs per month)
Acute medications that were allowed in this study included triptans, ergotamine derivatives, NSAIDs (nonsteroidal anti-inflammatory drugs), and acetaminophen.1
In REGAIN, statistical significance vs placebo was not observed after controlling for multiple comparisons for reduction in mean MHDs with acute medication use.1
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 placebo1,4-8
ap<0.001 vs placebo.
Review study design for EVOLVE-1 and EVOLVE-2
See data for chronic migraine or the 12-month, open-label safety study
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.
With Emgality, I don’t miss those moments...I get to be a part of the memories that we create.
— Bonnie, a patient with episodic migraine
Watch Bonnie’s storybPatients were compensated for their time.
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
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.
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
SELECT IMPORTANT SAFETY INFORMATION
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 Migraine-Specific Quality of Life Questionnaire v2.1 Role Function-Restrictive (RF-R), Emgality demonstrated a mean improvement from baseline vs placebo over Months 4 to 6.1
Emgality demonstrated a mean improvement of 32.4 points from baseline (N=189) vs 24.7 points with placebo (N=377) over Months 4 to 6 (baseline: 51.4 points vs 52.9 points) (p<0.001).1
Emgality demonstrated a mean improvement of 28.5 points from baseline (N=213) vs 19.7 points with placebo (N=396) over Months 4 to 6 (baseline: 52.5 points vs 51.4 points) (p<0.001)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
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.
Patients completed the Role Function-Restrictive (RF-R) domain of the MSQ v2.1, a functional impact tool1,13
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
Migraine study designs1,2
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.
≥50% response rates in patients with varying levels of prior preventive exposure14-16
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
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 monthly MHDs in patients with or without baseline acute medication overuse18,19a
19% of patients in both the EVOLVE-1 and EVOLVE-2 studies overused acute medication at baseline20,21
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 trials1,4,5
EVOLVE-1 (North America) and EVOLVE-2 (Global) were 6-month, randomized, multicenter, double-blind, placebo-controlled studies in patients with episodic migraine1,4,5
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 endpoints1,2
- 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 6a
- 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.
Review safety profile or the results from the 12-month, open-label safety study for 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. Stauffer VL, Dodick DW, Zhang Q, et al. Evaluation of galcanezumab for the prevention of episodic migraine: the EVOLVE-1 randomized clinical trial. JAMA Neurol. 2018;75(9):1080-1088. 5. Skljarevski V, Matharu M, Millen BA, et al. Efficacy and safety of galcanezumab for the prevention of episodic migraine: results of the EVOLVE-2 Phase 3 randomized controlled clinical trial. Cephalalgia. 2018;38(8):1442-1454. 6. Aimovig [Prescribing Information]. Thousand Oaks, CA: Amgen Inc.; 2019. 7. Ajovy [Prescribing Information]. North Wales, PA: Teva Pharmaceuticals USA, Inc.; 2019. 8. Vyepti [Prescribing Information]. Bothell, WA: Lundbeck Seattle BioPharmaceuticals, Inc.; 2020. 9. Data on File. Lilly USA, LLC. DOF-GZ-US-0147. 10. Data on File. Lilly USA, LLC. DOF-GZ-US-0148. 11. Data on File. Lilly USA, LLC. DOF-GZ-US-0012. 12. Data on File. Lilly USA, LLC. DOF-GZ-US-0010. 13. 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. 14. Data on File. Lilly USA, LLC. DOF-GZ-US-0025. 15. Data on File. Lilly USA, LLC. DOF-GZ-US-0015. 16. Data on File. Lilly USA, LLC. DOF-GZ-US-0016. 17. 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. 18. Data on File. Lilly USA, LLC. DOF-GZ-US-0092. 19. Data on File. Lilly USA, LLC. DOF-GZ-US-0091. 20. Data on File. Lilly USA, LLC. DOF-GZ-US-0090. 21. Data on File. Lilly USA, LLC. DOF-GZ-US-0084. 22. Data on File. Lilly USA, LLC. DOF-GZ-US-0024. 23. Data on File. Lilly USA, LLC. DOF-GZ-US-0018. 24. Data on File. Lilly USA, LLC. DOF-GZ-US-0017. 25. Data on File. Lilly USA, LLC. DOF-GZ-US-0029.