Emgality 300 mg: First and only CGRP antibody proven to treat patients with episodic cluster headache1,2
For your patients with episodic cluster headachea,
- 1 to 4 cluster attacks per day during active periods that last 7 weeks, followed by periods (≥3 months) of remission
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 300 mg significantly reduced the number of weekly cluster headache attacks1
aLeast-square (LS) means are presented.
bp=0.036 vs placebo.
Mean reduction in weekly cluster headache attack frequency over Weeks 1 to 3 (baseline: 17.8 for Emgality vs 17.3 for placebo). Patients on Emgality 300 mg (N=49) experienced a mean reduction in weekly headache attack frequency of -8.7b vs -5.2 for placebo (N=57)1,3a
ADDITIONAL INFORMATION:
Reduction in cluster headache frequency was averaged over Weeks 1 to 3.1
KEY HIGHLIGHT:
Patients experienced significantly fewer weekly cluster headache attacks with Emgality 300 mg.1
Emgality 300 mg makes a difference after the first dose1,4
Mean change in weekly cluster headache attack frequency over Weeks 1 to 31,4:
- At Week 1, patients on Emgality 300 mg (N=49) experienced a mean change in baseline of -5.4 vs -3.6 on placebo (N=57)
- At Week 2, patients on Emgality 300 mg experienced a mean change in baseline of -9.1 vs -4.5 on placebo
- At Week 3, patients on Emgality 300 mg experienced a mean change in baseline of -11.6 vs -7.6 with placebo
Difference from placebo was observed at Week 2 and Week 3.
LS=least square; SE=standard error.
Review Episodic Cluster Headache study design
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Contraindications
Emgality is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients.
Secondary Endpoint Result
Emgality 300 mg cut weekly cluster headache attacks in half or more for most patients at Week 31
71.4% of patients on Emgality 300 mg achieved a ≥50% reduction from baseline vs 52.6% of patients on placebo (p=0.046)1
Percentage of patients achieving ≥50% reduction in weekly cluster headache attack frequency on Emgality 300 mg (N=49) was 71.4%a vs 52.6% on placebo (N=57)1
ap=0.046 vs placebo.
KEY HIGHLIGHT:
With Emgality 300 mg, 71.4% of patients experienced half as many weekly cluster headache attacks vs 52.6% with placebo.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.
Emgality 300 mg: The only approved dose for patients with episodic cluster headache1,2
The Emgality Episodic Cluster Headache Study was an 8-week, randomized, double-blind, placebo-controlled study in adult patients1
Patient population (N=106)1
-
106 adults with episodic cluster headache enrolled
- Patients met International Classification of Headache Disorders-3 beta (ICHD-3 beta) diagnostic criteria for episodic cluster headache and had a maximum of 8 attacks per day, a minimum of 1 attack every other day, and at least 4 attacks during the prospective 7-day baseline period
8-week treatment period1
- Participants were randomized to once-monthly Emgality 300 mg or placebo
- Patients were allowed to use certain specified acute/abortive cluster headache treatments, including triptans, oxygen, acetaminophen, and nonsteroidal anti-inflammatory drugs (NSAIDs) during the study
Exclusion criteria1
- Patients on other treatments intended to reduce the frequency of cluster headache attacks
- Patients with medication overuse headache
- Patients with electrocardiogram (ECG) abnormalities compatible with an acute cardiovascular event or conduction delay
- Patients with a history of myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass grafting, deep vein thrombosis, or pulmonary embolism within 6 months of screening
- Patients with any history of stroke, intracranial or carotid artery aneurysm, intracranial hemorrhage or vasospastic angina, clinical evidence or peripheral vascular disease, or diagnosis of Raynaud’s disease were excluded
Prespecified key endpoints1,3
- Primary endpoint: LS mean change from baseline in weekly cluster headache attack frequency over Weeks 1 to 3
- Secondary endpoint: Percentage of patients who achieved a response (defined as a reduction from baseline of ≥50% in weekly cluster attack frequency) at Week 3
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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.
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bGovernmental beneficiaries excluded; terms and conditions apply.
References:
- Emgality [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC.
- Data on File. Lilly USA, LLC. DOF-GZ-US-0085.
- Data on File. Lilly USA, LLC. DOF-GZ-US-0120.
- Data on File. Lilly USA, LLC. DOF-GZ-US-0093.