FDA approves first treatment for episodic cluster headache that reduces the frequency of attacks

FDA on Tuesday approved galcanezumab-gnlm (Emgality—Eli Lilly) solution for injection for the treatment of episodic cluster headache in adults.

FDA on Tuesday approved galcanezumab-gnlm (Emgality—Eli Lilly) solution for injection for the treatment of 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, MD., deputy director of the Division of Neurology Products in FDA's Center for Drug Evaluation and Research. A clinical trial that compared galcanezumab-gnlm with placebo in 106 patients found that, over a 3-week period, patients receiving galcanezumab-gnlm had 8.7 fewer weekly cluster headache attacks than they did at baseline, compared with 5.2 fewer attacks for placebo recipients. FDA noted that there is a risk of hypersensitivity reactions with galcanezumab-gnlm use, and treatment should be discontinued if such a reaction occurs. The most common adverse effect reported by patients in the clinical trial was injection site reactions. Galcanezumab-gnlm, which is given by patient self-injection, was first approved by FDA in September 2018 for the preventive treatment of migraine in adults.