Indianapolis-based Eli Lilly and Co. (NYSE: LLY) says three Phase 3 studies of a treatment for episodic and chronic migraine have met with success. The pharmaceutical giant says the studies of galcanezumab showed "statistically significant reductions" in migraines among the participating patients.
Lilly says the most commonly-reported side effects of the drug were reactions at the injection site, including pain. As a result of the studies, Lilly plans to submit a Biologics License Application for the drug with the U.S. Food and Drug Administration in the second half of 2017.
"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."
Lilly says it will also make submissions to regulatory agencies throughout the world. The company plans to present data from the studies at scientific meetings later in the year and submit the results to peer-reviewed journals.
Additionally, Lilly says it is evaluating the drug for the treatment of cluster headache. Results of a Phase 3 trial are expected next year.