Positive phase III data for Emgality for episodic cluster headache is published in NEJM

Eli Lilly and Company announced that the New England Journal of Medicine published positive Phase III study results of Emgality (galcanezumab-gnlm) for the treatment of episodic cluster headache.

In this study, Emgality reduced the frequency of weekly cluster headache attacks across Weeks 1 to 3 compared to placebo.The FDA approval of Emgality for the treatment of episodic cluster headache in adults in June 2019 was based on these results.The study enrolled 106 patients who were randomized 1:1 to receive either 300 mg Emgality (via three 100 mg subcutaneous monthly injections) or placebo. Prior to enrollment, patients averaged 17.8 weekly cluster headache attacks in the Emgality arm (n=49) and 17.3 attacks in the placebo arm (n=57). Results showed that patients taking Emgality had an average reduction of 8.7 weekly cluster headache attacks across Weeks 1 to 3 compared to a 5.2 average reduction in attacks for placebo (p=0.036). Additionally, 71.4% of patients treated with Emgality had their weekly cluster headache attack frequency reduced by 50% or more at Week 3, the key secondary endpoint, compared to 52.6% of placebo-treated patients (p=0.046).

See- Goadsby PJ, Dodick DW, Leone M, "Trial of galcanezumab in prevention of episodic cluster headache". New England Journal of Medicine. 2019;382(2).

Comment: Emgality was FDA approved to treat Episodic Cluster Headache on 6 June 2019.