FDA Approves First Drug to Treat Episodic Cluster Headaches in Adults

The FDA has expanded the indication for Emgality (galcanezumab-gnlm, Eli Lilly) to treat episodic cluster headaches in adults, the first drug approved for the condition.

When administered to adult patients suffering episodic cluster headaches and compared against patients that received a placebo treatment, those that took Emgality experienced an average of 8.7 fewer weekly cluster headache attacks than they did at baseline. Those patients who received the placebo only experienced an average of 5.2 fewer attacks. One hundred and six patients participated in the trial, and cluster headache frequency was measured over the course of three weeks before being compared to changes from the baseline records. 

“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 in a statement.

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Emgality is a monoclonal antibody that binds to a calcitonin gene-related peptide, thereby inhibiting binding to the receptor. Approved in 2018, the drug was initially indicated for migrane headaches in adults. According to Eli Lilly, no relevant information on the pharmacodynamic effects of the drug is currently available. 

A dosage of 300 mg of galcanezumab-gnlm is indicated for cluster headaches, subcutaneously injected by the patient. The injections can be made into the abdomen, thigh, back of the upper arm, or buttocks in three consecutive 100 mg injections at the onset of a cluster period. Patients are to continue injections monthly until the end of the cluster period. Individual vials of 100 mg are available for the indication of cluster headaches. 

Emgality is contraindicated for patients with serious hypersensitivity reactions to galcanezumab-gnlm or any of its excipients. The most common adverse reactions reported throughout clinical trials were injection site reactions. 

Full Prescribing Information     Emgality Website