Eli Lilly announced full results from a positive Phase 3 study of patients with episodic cluster headache treated with Emgality. Detailed primary and secondary results will be presented Saturday, June 30 as a late-breaking presentation at the American Headache Society (AHS) annual meeting in San Francisco. Lilly also announced today that the intended brand name, Emgality,, has been conditionally accepted by the U.S. Food and Drug Administration. In this study, patients with episodic cluster headache treated with Emgality experienced statistically significant differences in the reduction of weekly cluster headache attacks compared to patients treated with placebo across Weeks 1 to 3 of the two-month, double-blind treatment period (-8.7 for Emgality compared to -5.2 for placebo, p=0.036), the primary endpoint of the study. Three out of four patients (76%) treated with Emgality (300 mg once-monthly) achieved at least a 50 percent reduction in weekly cluster headache attacks compared to 57% for placebo at Week 3 (p=0.04), the gated secondary endpoint. Additionally, 73 percent of patients treated with Emgality reported improvements based on the Patient Global Impression of Improvement (PGI-I) at Week 4, compared to 46% for placebo (p=0.016).
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