Emgality 300 mg: First and only calcitonin gene-related peptide (CGRP) antibody proven to treat patients with episodic cluster headache^1,2

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.

Emgality 300 mg makes a difference after the first dose^1,4

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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

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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 Episodic Cluster Headache study design

Emgality 300 mg: The only approved dose for patients with episodic cluster headache^1,5

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 endpoints^1,3

• 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.