Eli Lilly and Co. said three of its Phase 3 studies of galcanezumab, an investigational treatment to prevent episodic and chronic migraines, have found that galcanezumab significantly reduces the amount of migraine headache days experienced by sufferers.
The results of the studies were presented at the American Headache Society’s annual scientific meeting in Boston earlier this month, Lilly said in a release.
The Phase 3 studies, EVOLVE-1, EVOLVE-2, and REGAIN, also addressed the latest data on several important secondary endpoints for galcanezumab versus a placebo at both studied doses, Lilly said in a press release.
"The detailed Phase 3 results presented today represent a crucial step forward for the millions of patients living with migraine who have not yet tried, or found, an effective preventive therapy," Christi Shaw, president of Lilly Bio-Medicines, said in the release. "Following more than 25 years of research in migraine, Lilly is excited to help usher in a new era of preventive migraine therapies that may substantially improve the current standard of care for people living with migraine."
In EVOLVE-1 and EVOLVE-2 studies, a statistically significantly greater percentage of patients treated with both doses of galcanezumab achieved at least a 50 percent, 75 percent and 100 percent decrease in migraine headache days versus placebo over treatment period of six months, Lilly said.
Following the results of the studies, Lilly will turn in its Biologics License Application for galcanezumab to the Food and Drug Administration n the second half of 2017 and submit its study findings for peer-review journal publication over the next year, Lilly said. The company said it also will submit its results to additional regulatory agencies around the world.