Discover what Emgality can do for patients with chronic migraine1
For your patients with ≥15 headache days per month,1
Meet a patient with chronic migrainea
CLINICAL FACTORS
- 15 or more unpredictable headache days per month
- Has tried therapeutic doses of 2 standard-of-care generic preventives
- May now be only relying on her acute treatments
aHypothetical patient profile.
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Contraindications
Emgality is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients.
Primary Endpoint Result
Emgality prevented significantly more mean monthly MHDs vs placebo1a:
- REGAIN: 4.8 with Emgality vs 2.7 with placebo (baseline mean: 19.4 vs 19.6) over Months 1 to 3 (p<0.001)
Emgality demonstrated a reduction in MHDs in the first month and every following month1
aLS means and 95% confidence intervals are presented.1,2,4
bEarliest post-baseline, prespecified assessment.
In REGAIN, mean change from baseline in monthly MHDs
Emgality 120 mg (N=273) vs placebo (N=538), respectively1,2a:
- Month 1: -4.1b vs -1.8b
- Month 2: -5.0 vs -3.0
- Month 3: -5.4 vs -3.4
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 REGAIN
See data for episodic 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.
A migraine-free day for me means being able to play with the kids before putting them to bed.
— Leia, a patient with chronic migraine
Watch Leia’s storybPatients were compensated for their time.
Secondary Endpoint Result
With Emgality, a significantly greater mean percentage of patients achieved a ≥50% reduction in monthly migraine headache days (MHDs) from baseline vs placebo1
ap<0.001 vs placebo.
Twenty-eight percent of patients with chronic migraine taking Emgality 120 mg (N=273) achieved a ≥50% reduction in monthly MHDs from baseline vs 15% with placebo (N=538) over Months 1 to 3 (p>0.001).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
Review study design for REGAIN
See response rate data for episodic migraine or the 12-month, open-label safety study
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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.
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 storybPatients were compensated for their time.
Emgality was studied as a preventive treatment for chronic migraine in a Phase 3 trial1,3
REGAIN was a 3-month, randomized, multicenter, double-blind, placebo-controlled study conducted in the United States and 11 other countries1,3
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 endpoints1,4
- 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 3a
- 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
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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.
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.