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FDA approves first drug for episodic cluster headache
The FDA approved Emgality for treatment of episodic cluster headache in adults. Emgality (galcanezumab-gnlm, Eli Lilly) is the first drug approved for the condition.
“The FDA is committed to continuing to work with drug developers to bring treatments for unmet medical needs to patients,” Eric Bastings, MD, deputy director of the division of neurology products at the FDA’s Center for Drug Evaluation and Research, said in an FDA release.
“The approval of Emgality for the treatment of episodic cluster headache is a cause for celebration and hope,” Bob Wold, founder of Clusterbusters Inc., said in an Eli Lilly release.
Emgality’s recommended dosage is three consecutive 100-mg subcutaneous injections at the start of a cluster headache period and then monthly until the cluster period’s end. The drug’s use carries a risk for hypersensitivity reactions, and the most common adverse event was injection site reactions.
Healio Primary Care previously reported on how galcanezumab-gnlm had been given FDA priority review after a 3-week trial in which 71.4% of 49 patients who received the medication had their cluster headaches per week drop by more than half.
Disclosures: Bastings is employed by the FDA.