> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Lilly’s Emgality Approved for Cluster Headaches
- URL: https://www.fdaweb.com/lillys-emgality-approved-for-cluster-headaches/
- Published: 2019-06-05T12:00:00.000Z
- Updated: 2026-09-15T01:30:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144263

FDA has approved an Eli Lilly BLA for Emgality (galcanezumab-gnlm) solution for injection for treating episodic cluster headache in adults. The drug was first approved 9/2018 for preventing migraine headaches in adults.

The new approval was based on data from a 106-patient placebo-controlled clinical trial. “The trial measured the average number of cluster headaches per week for three weeks and compared the average changes from baseline in the Emgality and placebo groups,” an [agency release](https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-episodic-cluster-headache-reduces-frequency-attacks?ref=fdaweb.com) says. “During the 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.”  

FDA says that there is a risk of hypersensitivity reactions with Emgality use. If such a reaction occurs, treatment should be discontinued, it says. “Hypersensitivity reactions could occur days after administration and may be prolonged,” it adds. “The most common side effect reported by participants in the clinical trials was injection site reactions.”