FDA ‘yes’ for Emgality in cluster headache

The US Food and Drug Administration (FDA) has announced the approval of the first treatment for episodic cluster headache that reduces the frequency of attacks, Eli Lilly’s Emgality (galcanezumab-gnlm).

The decision is based on a clinical trial that compared the drug to placebo in 106 patients, and found that during a three-week period, patients taking Emgality experienced 8.7 fewer weekly cluster headache attacks than they did at baseline, compared to 5.2 fewer attacks for patients on placebo.

"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, deputy director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research.

He also said that "The FDA is committed to continuing to work with drug developers to bring treatments for unmet medical needs to patients."

The once-monthly monoclonal antibody injection was approved by the European Commission for preventive treatment of migraine in adults last November, just one month after the FDA also green-lighted the drug for migraine.

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 or nasal congestion and facial sweating.

The FDA also granted this application Priority Review and Breakthrough Therapy designation.

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