Indianapolis-based Eli Lilly and Co. (NYSE: LLY) says a 12-month Phase 3 study of a migraine treatment has shown continued positive results. The pharmaceutical giant says the study for galcanezumab showed a "statistically significant reduction in the number of monthly migraine headache days" among patients.
Lilly says the treatment "demonstrated a positive safety and tolerability profile in patients with migraine, consistent with previous studies." Patients received two different doses and the company says there was "no clinically meaningful difference" in the rate of adverse effects between the dosages.
Lilly’s previously-announced plans to submit a Biologics License Application to the U.S. Food and Drug Administration remain set for the second half of 2017. The company also plans to submit to other regulatory agencies throughout the world.
"These long-term results are significant for the millions of Americans with migraine. They reinforce the efficacy and safety profile of galcanezumab while supporting its potential use as a self-administered, monthly injection," said Christi Shaw, president of Lilly Bio-Medicines. "After more than two decades of research, Lilly is excited to submit galcanezumab to the FDA as a new potential treatment option that can provide more migraine-free days for people suffering with migraine."
Lilly is presenting the results of the study at the 18th Congress of the International Headache Society in Vancouver. The company also plans to submit the findings for publication in a peer-reviewed journal "in the coming year."
The announcement comes just one day after Lilly detailed plans for a global restructuring, affecting about 3,500 employees. The company said the move will allow it to invest in the next generation of new medicines.