FDA Approves First Treatment for Episodic Cluster Headaches

The US Food and Drug Administration has approved the first-ever treatment for episodic cluster headache in adults that reduces the frequency of attacks.

The drug, Emgality (galcanezumab-gnlm), is an injection medication originally approved for preventing migraine in adults in September 2018.

This approval comes after a clinical trial comparing Emgality to placebo (N=106) showed that patients taking Emgality experienced 8.7 fewer cluster headache attacks than patients taking placebo after 3 weeks.

The most commonly reported adverse reaction during the trial was injection site reactions.

“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, MD, 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.”

—Amanda Balbi


FDA approves first treatment for episodic cluster headache that reduces the frequency of attacks [press release]. Silver Spring, MD; US Food and Drug Administration; June 4, 2019. Accessed June 5, 2019.