Lilly's Galcanezumab Meets Primary Endpoint

Eli Lilly and Company announced galcanezumab met its primary endpoint in a Phase 3 study of patients with episodic cluster headache, demonstrating statistically significant differences in the reduction of weekly cluster headache attacks compared to placebo across weeks one to three of the two-month, double-blind treatment period. A statistically significantly greater percentage of patients treated with galcanezumab also achieved at least a 50 percent reduction in weekly cluster headache attacks compared to placebo at Week 3, the gated secondary endpoint.

The observed safety and tolerability profile was consistent with previous studies that evaluated galcanezumab for the prevention of migraine. In this study, 8 percent of patients treated with galcanezumab discontinued treatment during the study compared to 21 percent of patients treated with placebo. Four percent of patients treated with galcanezumab discontinued treatment during the study due to adverse events compared to 2 percent of patients treated with placebo. Discontinuations due to lack of efficacy occurred in 2 percent of patients treated with galcanezumab, compared to 14 percent of patients treated with placebo.

"Cluster headache can be difficult to evaluate in clinical studies, which has contributed to few available treatment options for cluster headache, often considered the most severe pain one can experience," said Christi Shaw, president of Lilly Bio-Medicines. "The positive results in episodic cluster headache are truly a landmark moment—both for people living with cluster headache and for our researchers at Lilly, many of whom have spent more than two decades researching and developing innovative, non-opioid treatment options for diseases like migraine and cluster headache."

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