Emgality 300 mg: First and only calcitonin gene-related peptide (CGRP) antibody proven to treat patients with episodic cluster headache1,2

Meet Frank, a patient with episodic cluster headache

aHypothetical patient profile.

Life with fewer episodic cluster headache attacks is possible with Emgality 300 mg1

For your patients with episodic cluster headache,

Emgality 300 mg significantly reduced the number of weekly cluster headache attacks1

Graph of mean reduction in weekly cluster headache attack frequency

aLeast-square (LS) means are presented.

bp=0.036 vs placebo.

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Reduction in cluster headache frequency was averaged over Weeks 1 to 3.1

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Patients experienced significantly fewer weekly cluster headache attacks with Emgality 300 mg.1

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

Emgality 300 mg makes a difference after the first dose1,4

Difference from placebo observed at Week 2

Graph of mean change in weekly cluster headache attack frequency

SE=standard error.

Emgality 300 mg: The only approved dose for patients with episodic cluster headache1,5

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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cGovernmental beneficiaries excluded.

References: 1. Emgality [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC. 2. Data on File. Lilly USA, LLC. DOF-GZ-US-0121. 3. Data on File. Lilly USA, LLC. DOF-GZ-US-0120. 4. Data on File. Lilly USA, LLC. DOF-GZ-US-0093. 5. Data on File. Lilly USA, LLC. DOF-GZ-US-0085.

Indications and Important Safety Information

Emgality is a calcitonin gene-related peptide (CGRP) antagonist indicated in adults for the:

  • Preventive treatment of migraine
  • Treatment of episodic cluster headache

Important Safety Information

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

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.

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

Please see Full Prescribing Information, including Patient Information, for Emgality. See Instructions for Use included with the device.