FDA Approves Galcanezumab as First Episodic Cluster Headache Drug


The approval is based on the findings of a 106-adult patient trial which assessed mean weekly headache episodes.


The US Food and Drug Administration (FDA) has approved galcanezumab solution injection (Emgality) as the first treatment for reducing episodic cluster headaches in adult patients.

The indication was granted to Eli Lilly’s self-injection monoclonal antibody that made headlines in September 2018 after earning FDA approval for the preventive treatment of migraines in adults.

Galcanezumab’s efficacy was demonstrated in a clinical trial comparing the drug to placebo in 106 patients with episodic cluster headaches. Investigators assessed for rates of mean weekly cluster headaches over 3 weeks compared to mean baseline counts.

They reported that patients administered galcanezumab experienced 8.7 fewer weekly cluster headache attacks than they did at baseline, versus just 5.2 fewer for those administered placebo. Hypersensitivity reactions have been frequently reported in patients administered therapy—in which case physicians are advised to discontinue treatment. The common side effect among patients in the clinical trial was injection site reactions.

Patients who suffer from cluster headache often experience extreme pain—often at the same time of day, over the period of several weeks to months. The headaches often bring symptoms of bloodshot eyes, excessive tearing, drooping eyelids, and nasal congestion. A cluster headache attack could occur several times over 1 day, lasting anywhere from 15 minutes to 3 hours.

The FDA previously granted the supplemental New Drug Application Priority Review and Breakthrough Therapy designation, indicating galcanezumab’s potential for an at-need indication.

Eric Bastings, MD, deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, expanded on the commitment of the administration to address this critical patient population.

“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,” Bastings said in a statement.

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