Galcanezumab (Emgality ) Gets FDA OK for Cluster Headache

Megan Brooks

June 04, 2019

The US Food and Drug Administration (FDA) has approved the calcitonin gene-related peptide (CGRP) antagonist galcanezumab-gnlm (Emgality, Eli Lilly and Co) for the treatment of episodic cluster headache in adults.

Galcanezumab is given by patient self-injection. It was first approved by the FDA in September 2018 for the prevention of migraine in adults, as reported by Medscape Medical News.

"Emgality provides patients with the first FDA-approved drug that reduces the frequency of attacks of episodic cluster headache, an extremely painful and often debilitating condition," Eric Bastings, MD, deputy director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research, said in a news release.

Cluster headache produces extreme pain and tends to occur in clusters, often at the same time(s) of the day, for several weeks to months. Cluster headache is often accompanied by bloodshot eyes, excessive tearing of the eyes, drooping of the eyelids, runny nose and/or nasal congestion, and facial sweating. Some people experience restlessness and agitation. Cluster headache attacks may strike several times a day, generally lasting between 15 minutes and 3 hours.

Galcanezumab for episodic cluster headache was assessed in a clinical trial that compared the drug with placebo in 106 patients. The trial measured the average number of cluster headaches per week for 3 weeks and compared the average changes from baseline in the galcanezumab and placebo groups.

During the 3-week period, patients taking galcanezumab experienced 8.7 fewer weekly cluster headache attacks than they did at baseline, compared with 5.2 fewer attacks for patients on placebo.

The most common side effect reported by participants in the clinical trials was injection-site reactions.

The FDA notes that there is a risk for hypersensitivity reactions with galcanezumab use. If a serious hypersensitivity reaction occurs, treatment should be discontinued. Hypersensitivity reactions could occur days after administration and may be prolonged.

Galcanezumab received priority review and breakthrough therapy designation.

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