FDA Approves First Treatment for Cluster Headaches

June 6, 2019

The U.S. Food and Drug Administration (FDA) has approved Emgality (galcanezumab-gnlm) solution for injection, the first treatment for 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 headaches often occur at the same time(s) of the day for several weeks to months and produce extreme pain, according to the FDA. The attacks may strike several times a day, generally lasting between 15 minutes and three hours.

Read the full release.