First treatment for cluster headaches approved in US

The US Food and Drug Administration (FDA) has announced its approval for the first treatment of episodic cluster headache in the CGRP inhibitor class. The monthly monoclonal antibody injection is also the first drug of its kind to decrease the frequency of attacks.  

A clinical trial held over three weeks studied 106 patients. Those who took the 300mg drug experienced 8.7 fewer weekly cluster headache attacks than at baseline. Comparatively, patients taking the placebo had 5.2 fewer attacks.

The Emgality (galcanezuman-gnlm) drug was developed by Eli Lilly. A gap in the market for the drug helped to enable its sanction by the FDA.   

The American Migraine Trust approximates that cluster headaches affect 200,000 to 1 million people in the US.

Last November, the treatment was approved by the European Commission for preventative treatment of migraines.

Eric Bastings, deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, said that "The FDA is committed to continuing to work with drug developers to bring treatments for unmet medical needs to patients."

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

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