Positive results for Lilly's three Phase III studies of galcanezumab for the prevention of migraine

"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," said Christi Shaw, president of Lilly Bio-Medicines. "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 FDA for galcanezumab in the second half of 2017, followed by submissions to other regulatory agencies around the world.