FDA approves new indication for Lilly’s Emgality

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FDA approves new indication for Lilly’s Emgality

By Sandra Levy - 06/05/2019
Eli Lilly has received the Food and Drug Administration’s nod for Emgality (galcanezumab-gnlm solution for injection) for the treatment of episodic cluster headache in adults. It was first approved by the FDA in September 2018 for the preventive treatment of migraine 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,” deputy director of the division of neurology products in the FDA’s Center for Drug Evaluation and Research Eric Bastings said. “The FDA is committed to continuing to work with drug developers to bring treatments for unmet medical needs to patients.”

Cluster headache is a form of headache that produces extreme pain and tends to occur in clusters, often at the same time of the day, for several weeks to months. The headaches are accompanied by symptoms that may include: bloodshot eyes, excessive tearing of the eyes, drooping of the eyelids, runny nose and/or nasal congestion and facial sweating. Some people experience restlessness and agitation. Cluster headache attacks may strike several times a day, generally lasting between 15 minutes and three hours.

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