Eli Lilly announced galcanezumab, an investigational treatment for the prevention of episodic and chronic migraine, met its primary endpoint in three Phase 3 studies (EVOLVE-1, EVOLVE-2 and REGAIN) demonstrating statistically significant reductions in the number of monthly migraine headache days compared to placebo at both studied doses.
"The robust results from these three studies bring us one step closer to helping people experience more migraine-free days, an important treatment goal for those living with this serious disease," Christi Shaw, president of Lilly Bio-Medicines said. "The impact of migraine is underestimated, with people who experience migraine attacks often missing work, family activities or social engagements. For patients with as few as one migraine headache day per week, this can mean more than 50 days of lost productivity a year."
In these three studies, the most commonly-reported adverse events were injection site reactions, including pain. The observed safety and tolerability profile was consistent with findings from previous studies of galcanezumab.
Based on these results, Lilly will submit a Biologics License Application to the U.S. Food and Drug Administration (FDA) for galcanezumab in the second half of 2017, followed by submissions to other regulatory agencies around the world.
In the EVOLVE-1 and EVOLVE-2 studies, over the six-month treatment period, patients with episodic migraine treated with galcanezumab 120 mg and 240 mg doses experienced a significantly greater decrease in the average number of monthly migraine headache days compared to patients treated with placebo.
Additionally, patients treated with galcanezumab experienced statistically significant improvement compared to placebo on several pre-specified secondary endpoints, including response rates and measures of daily activities.
During the REGAIN Study, over the three-month treatment period, patients with chronic migraine treated with galcanezumab 120 mg and 240 mg doses experienced a significantly greater decrease in the average number of monthly migraine headache days compared to patients treated with placebo (average reduction of 4.8 days for 120 mg and 4.6 days for 240 mg compared to an average reduction of 2.7 days for placebo, p<0.001 for both dosing groups).
Additionally, patients treated with galcanezumab experienced statistically significant improvement compared to placebo on several pre-specified secondary endpoints, including response rates and measures of daily activities.
Lilly also is evaluating galcanezumab for the treatment of cluster headache, with Phase 3 trial results expected in 2018. Based on the unmet medical need and significance of this disease for patients, Lilly has been granted Fast Track Designation from the FDA.
Migraine is a neurological disease characterized by recurrent episodes of severe headache, and is often accompanied by other symptoms including nausea, vomiting, sensitivity to light and sound, and changes in vision. More than 38 million Americans have migraine, with three times more women affected by migraine compared to men.