FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Lilly Wins Expanded Indication for Migraine Drug

June 13, 2019

The FDA expanded its approval of Eli Lilly’s migraine drug Emgality to include treatment of episodic cluster headaches.

Emgality (galcanezumab-gnlm) was approved for migraines last September. It’s the first drug to win FDA approval for cluster headaches.

The indication was supported by data from a clinical trial of 106 patients that found patients treated with Emgality had 8.7 fewer cluster headaches compared to their baseline, as opposed to 5.2 fewer attacks for patients in the placebo group.

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