Eli Lilly announces Phase 3 Emgality study results published
Eli Lilly announced that the New England Journal of Medicine published Phase 3 study results of Emgality 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 was based on these results. The study enrolled 106 patients who were randomized 1:1 to receive either 300 mg Emgality or placebo. Prior to enrollment, patients averaged 17.8 weekly cluster headache attacks in the Emgality arm and 17.3 attacks in the placebo arm. 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. 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. Overall, the safety profile observed in patients with episodic cluster headache treated with Emgality 300 mg monthly is consistent with the safety profile in patients with migraine treated with Emgality 120 mg monthly. Two Emgality-treated patients discontinued double-blind treatment during the episodic cluster headache study because of adverse events.