TUESDAY, June 4, 2019 -- The U.S. Food and Drug Administration granted Emgality (galcanezumab-gnlm) solution the first approval for treating episodic cluster headache, the agency announced yesterday.
Previously approved for preventive treatment of migraine in adults, Emgality is administered through patient self-injection. The recommended dosage of Emgality for treatment of episodic cluster headache is 300 mg administered as three 100-mg injections at the initial onset of cluster headaches and then monthly doses of 120 mg until the end of the cluster period.
The drug's approval for treatment of episodic cluster headache was based on a clinical trial of 106 patients. At three weeks, patients taking Emgality had 8.7 fewer weekly cluster headache attacks from baseline compared with 5.2 fewer attacks for patients who were taking placebo.
Injection site reactions were the most commonly reported side effect. Emgality puts patients at risk for hypersensitivity reactions and is contraindicated in patients with a serious hypersensitivity to galcanezumab-gnlm. The FDA states that patients should discontinue use if they experience such a reaction; hypersensitivity reactions could occur days after administration and could last for a prolonged period of time.
Approval was granted to Eli Lilly.