Discover what Emgality® can do for patients with episodic migraine1
For your patients with 4-14 MHDs per month,1
Meet Jessicaa
Migraine continues to impact her work and personal life during and between attacks
- 4-14 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
She isn’t sure another preventive will give her the results she is looking for.
aHypothetical patient profile with episodic migraine.
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
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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 period1
Emgality prevented significantly more mean monthly MHDs vs placebo1a:
- EVOLVE-1: 4.7 with Emgality vs 2.8 with placebo (baseline mean: 9.2 vs 9.1) over Months 1 to 6 (p<0.001)
- EVOLVE-2: 4.3 with Emgality vs 2.3 with placebo (baseline mean: 9.1 vs 9.2) over Months 1 to 6 (p<0.001)
aLS means and 95% confidence intervals are presented.1,2,12
bEarliest post-baseline, prespecified assessment.
EVOLVE-1
Mean change from baseline in monthly MHDs at each month over Months 1 to 6 in EVOLVE-11,2a:
- Month 1: Emgality following the loading dose of 240 mg was -3.7b vs - 1.7b for placebo
- Month 2: Emgality 120 mg was -4.4 vs -2.5 for placebo
- Month 3: Emgality 120 mg was -4.7 vs -3.0 for placebo
- Month 4: Emgality 120 mg was -5.1 vs -3.2 for placebo
- Month 5: Emgality 120 mg was -5.4 vs -3.1 for placebo
- Month 6: Emgality 120 mg was -5.2 vs -3.4 for placebo
210 patients were treated with Emgality 120 mg vs 425 patients treated with placebo.
EVOLVE-2
Mean change from baseline in monthly MHDs at each month over Months 1 to 6 in EVOLVE-21,2a:
- Month 1: Emgality following the loading dose of 240 mg was -3.9b vs - 1.2b for placebo
- Month 2: Emgality 120 mg was -4.0 vs -2.2 for placebo
- Month 3: Emgality 120 mg was -3.8 vs -2.2 for placebo
- Month 4: Emgality 120 mg was -4.5 vs -2.4 for placebo
- Month 5: Emgality 120 mg was -4.9 vs -2.9 for placebo
- Month 6: Emgality 120 mg was -4.6 vs -2.9 for placebo
226 patients were treated with Emgality 120 mg vs 450 patients treated with placebo.
No formal hypothesis testing was conducted to evaluate treatment difference in mean monthly MHD reduction at each month. However, patients treated with Emgality 120 mg showed a nominally greater reduction in number of monthly MHDs at each month compared to placebo.1,2
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 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)
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
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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.
Secondary Endpoint Results
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 placebo1,3-7
EVOLVE-1
Response rates defined levels of reduction in monthly MHDs over Months 1 to 6 in EVOLVE-11:
- Mean percentage of patients who experienced a ≥50% reduction in MHDs with Emgality 120 mg was 62% vs 39% with placebo
- Mean percentage of patients who experienced a ≥75% reduction in MHDs with Emgality 120 mg was 39% vs 19% with placebo
- Mean percentage of patients who experienced a 100% reduction in any month of the 6-month study was 16% with Emgality vs 6% with placebo
210 patients were treated with Emgality and 425 patients were treated with placebo.
EVOLVE-2
Response rates defined levels of reduction in monthly MHDs over Months 1 to 6 in EVOLVE-21:
- Mean percentage of patients who experienced a ≥50% reduction in MHDs with Emgality 120 mg was 59% vs 36% with placebo
- Mean percentage of patients who experienced a ≥75% reduction in MHDs with Emgality 120 mg was 34% vs 18% with placebo
- Mean percentage of patients who experienced a 100% reduction in any month of the 6-month study was 12% with Emgality vs 6% with placebo
226 patients were treated with Emgality and 450 patients were treated with placebo.
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.
For patients with 4-14 MHDs per month,
≥50% reduction in monthly MHDs from baseline at each month1,8,9
- EVOLVE-1: ≥50% reduction of monthly MHDs8
Emgality 120 mg (N=210) vs placebo (N=425), respectively:- Month 1: 49% vs 25%
- Month 2: 57% vs 36%
- Month 3: 63% vs 42%
- Month 4: 67% vs 43%
- Month 5: 70% vs 42%
- Month 6: 67% vs 46%
- EVOLVE-2: ≥50% reduction of monthly MHDs9
Emgality 120 mg (N=226) vs placebo (N=450)- Month 1: 53% vs 22%
- Month 2: 52% vs 33%
- Month 3: 54% vs 35%
- Month 4: 65% vs 41%
- Month 5: 67% vs 44%
- Month 6: 64% vs 43%
≥75% reduction in mean monthly MHDs from baseline at each month1,10
- EVOLVE-1: ≥75% reduction of monthly MHDs10
Emgality 120 mg (N=210) vs placebo (N=425), respectively:- Month 1: 26% vs 8%
- Month 2: 32% vs 15%
- Month 3: 39% vs 24%
- Month 4: 44% vs 25%
- Month 5: 45% vs 25%
- Month 6: 50% vs 25%
- EVOLVE-2: ≥75% reduction of monthly MHDs10
Emgality 120 mg (N=226) vs placebo (N=450)- Month 1: 26% vs 9%
- Month 2: 30% vs 14%
- Month 3: 30% vs 17%
- Month 4: 39% vs 22%
- Month 5: 39% vs 23%
- Month 6: 39% vs 26%
100% reduction in mean monthly MHDs from baseline at each month1,11
- EVOLVE-1: 100% reduction of monthly MHDs11
Emgality 120 mg (N=210) vs placebo (N=425), respectively:- Month 1: 9% vs 2%
- Month 2: 15% vs 3%
- Month 3: 16% vs 8%
- Month 4: 20% vs 10%
- Month 5: 19% vs 10%
- Month 6: 18% vs 10%
- EVOLVE-2: 100% reduction of monthly MHDs11
Emgality 120 mg (N=226) vs placebo (N=450), respectively:- Month 1: 9% vs 2%
- Month 2: 9% vs 4%
- Month 3: 9% vs 7%
- Month 4: 13% vs 7%
- Month 5: 16% vs 8%
- Month 6: 15% vs 9%
The response rates at each month are derived from the overall mean monthly response rate across the 6-month period, estimated using the generalized linear repeated measures model. Results at each month have not been adjusted for multiple comparisons. No conclusions of statistical significance can be drawn from the monthly response rates.1
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.1
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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.
Emgality was studied as a preventive treatment for episodic migraine in two Phase 3 trials1,3,4
EVOLVE-1 (North America) and EVOLVE-2 (Global) were 6-month, randomized, multicenter, double-blind, placebo-controlled studies in patients with episodic migraine1,3,4
Adult patient population (N=1773)1,3,4
- 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 endpoints1,11
- 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.1,12
Review study design for REGAIN
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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.
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.
- 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.
- 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.
- Aimovig [Prescribing Information]. Thousand Oaks, CA: Amgen Inc.; 2019.
- Ajovy [Prescribing Information]. North Wales, PA: Teva Pharmaceuticals USA, Inc.; 2019.
- Vyepti [Prescribing Information]. Bothell, WA: Lundbeck Seattle BioPharmaceuticals, Inc.; 2020.
- Data on File. Lilly USA, LLC. DOF-GZ-US-0147.
- Data on File. Lilly USA, LLC. DOF-GZ-US-0148.
- Data on File. Lilly USA, LLC. DOF-GZ-US-0171.
- Data on File. Lilly USA, LLC. DOF-GZ-US-0173.
- 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(3):409-421.