Eli Lilly and Company said results of three Phase III studies on using galcanezumab to prevent episodic and chronic migraines indicated it reduced monthly migraine days.
EVOLVE-1, EVOLVE-2 and REGAIN studies showed statistically significant results in reducing monthly migraine days, Lilly said in a release. The studies evaluated two different doses of galcanezumab versus a placebo.
"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," Lilly Bio-Medicines President Christi Shaw said in the release. "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."
Based on the positive results from the three studies, Lilly said it will submit a Biologics License Application to various regulatory agencies around the world, beginning with the U.S. Food and Drug Administration. The detailed data and results will also be submitted to peer-reviewed journals and at scientific meetings.
"Lilly's commitment to the development of new treatments for migraine has spanned more than 25 years, and in that time, we have played an important role in advancing the understanding of this serious disease," Robert Conley, distinguished Lilly Scholar and Lilly global development leader for migraine therapeutics, said in the release. "The topline results from these Phase 3 data are encouraging and reaffirm the potential for galcanezumab to provide a new option for people living with migraine."