FDA Gives Nod to New Treatment for Episodic Cluster Headache

June 7, 2019

Emgality (galcanezumab-gnlm) is the first FDA-approved drug that reduces the frequency of headache attacks.

The FDA has approved Emgality (galcanezumab-gnlm) injection (300 mg) for the treatment of episodic cluster headache in adults, announced the drug’s manufacturer, Eli Lilly and Company, in a press release.

“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 to the press.

Emgality is the first calcitonin gene-related peptide antibody approved by the FDA for two distinct headache disorders. It was initially approved in 2018 for the preventive treatment of migraine in adults.

After patients receive training from a health care professional, they can administer Emgality at home through subcutaneous injections at the onset of a cluster headache period, and then monthly until the end of a cluster period. The drug is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients.

The effectiveness of Emgality for the treatment of episodic cluster headache was demonstrated in a clinical trial that compared the drug with placebo in 106 patients. The trial measured the average number of cluster headaches per week for 3 weeks and compared the average changes from baseline in the Emgality and placebo groups. During the 3-week period, patients taking Emgality experienced 8.7 fewer weekly cluster headache attacks than they did at baseline, versus 5.2 fewer attacks for patients receiving placebo (P=.036).

References:

FDA approves Emgality® (galcanezumab-gnlm) as the first and only medication for the treatment of episodic cluster headache that reduces the frequency of attacks [press release]. Indianapolis, IN: Eli Lilly and Company; June 4, 2019.

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.