The U.S. Food and Drug Administration approved Emgality (galcanezumab-gnlm) solution for injection for the treatment of episodic cluster headache in adults.

“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,” said Eric Bastings, M.D., deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “The FDA is committed to continuing to work with drug developers to bring treatments for unmet medical needs to patients.”

Cluster headache is a form of headache that produces extreme pain and tends to occur in clusters, often at the same time(s) of the day, for several weeks to months. The headaches are accompanied by symptoms that may include: 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 three hours.

The effectiveness of Emgality for the treatment of episodic cluster headache was demonstrated in a clinical trial that compared the drug to placebo in 106 patients. The trial measured the average number of cluster headaches per week for three weeks and compared the average changes from baseline in the Emgality and placebo groups. During the three-week period, patients taking Emgality experienced 8.7 fewer weekly cluster headache attacks than they did at baseline, compared to 5.2 fewer attacks for patients on placebo.

There is a risk of hypersensitivity reactions with Emgality use. If a serious hypersensitivity reaction occurs, treatment should be discontinued. Hypersensitivity reactions could occur days after administration and may be prolonged. The most common side effect reported by participants in the clinical trials was injection site reactions.

Emgality is given by patient self-injection. It was first approved by the FDA in September 2018 for the preventive treatment of migraine in adults. The FDA granted the approval of Emgality to Eli Lilly.

The FDA granted this application Priority Review and Breakthrough Therapy designation.