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The Food and Drug Administration (FDA) has approved galcanezumab-gnlm (Emgality; Eli Lilly, Indianapolis, IN) for treatment of episodic cluster headache in adults. Galcanezumab is the only agent in the new class of calcitonin gene-related peptide (CGRP) inhibitors to be approved for treating cluster headache. Individuals with cluster headache can administer a 300-mg dose at home through 3 consecutive subcutaneous injections cluster headache period onset, followed by monthly doses until the period ends.
Approval was based upon a randomized 8-week double-blind placebo-controlled study (NCT02397473), in which individuals treated with galcanezumab had significantly more reduction in headache frequency. Those treated with galcanezumab vs placebo were more likely to have a 50% reduction in headache attacks (Table).
The safety profile seen in this study was similar to that seen in studies of galcanezumab for migraine prevention. The most common adverse event is injection site reaction.
Participants were allowed to use triptans, oxygen, acetaminophen, and NSAIDs to abort attacks during the study but were not allowed to use other treatments intended to reduce cluster headache attack frequency. Those with medication overuse headache or cardiopulmonary risk factors were not included in the study.
"Episodic cluster headache can be devastating. The approval of Emgality for the treatment of episodic cluster headache is an important milestone as it provides a new treatment option, which has been long-awaited by those impacted by this disease," said Christi Shaw, president, Lilly Bio-Medicines.
"As someone impacted by cluster headache and an advocate for others living with this disease, I know firsthand the desperation that we have felt for additional treatment options that can reduce the frequency of these attacks that have such a debilitating impact on our lives," said Bob Wold, founder, Clusterbusters, Inc. "The approval of Emgality for the treatment of episodic cluster headache is a cause for celebration and hope. On behalf of this community, we thank the FDA, Lilly, the researchers, and the patients who helped to usher forward this innovative treatment."
Jeffrey L. Cummings, MD, ScD; and Kate Zhong, MD
Douglas W. Scharre, MD
Liana Rosenthal, MD, PhD