Galcanezumab Shown to Significantly Cut Monthly Migraine Days

Eli Lilly announced positive results from their three Phase 3 studies of galcanezumab, an investigational treatment for the prevention of episodic and chronic migraine.

Galcanezumab, a monoclonal antibody specifically designed to bind to and inhibit the activity of calcitonin gene-related peptide (CGRP), is an investigational once-monthly, self-administered injection. The studies EVOLVE-1, EVOLVE-2, and REGAIN included a total of 2,886 patients with either episodic or chronic migraine. The studies evaluated doses of subcutaneous galcanezumab 120mg and 240mg vs. placebo.

The primary endpoint was the mean change from baseline in monthly migraine headache days over the 6-month treatment phase.

In EVOLVE-1, 62.3% and 60.9% of patients receiving galcanezumab 120mg and 240mg, respectively, had at least a 50% reduction in migraine days vs. 38.6% for placebo (P<0.001). A 100% reduction was seen in 15.6% and 14.6% of the galcanezumab groups, respectively, vs. 6.2% for placebo (P<0.001). 

 In EVOLVE-2, 59.3% and 56.5% of patients receiving galcanezumab 120mg and 240mg, respectively, had at least a 50% reduction in migraine days vs. 36.0% for placebo (P<0.001). A 100% reduction was seen in 11.5% and 13.8% of the galcanezumab groups, respectively, vs. 5.7% for placebo (P<0.001).

Patients in the galcanezumab group had statistically significant greater reduction in monthly migraine headache days with acute medication use compared to placebo. In addition, they saw statistically significant improvement in physical function vs. placebo as measured by the MSQ and PGI-S rating scales.  

In REGAIN,  27.6% and 27.5% of patients receiving galcanezumab 120mg and 240mg, respectively, had at least a 50% reduction in migraine days over the 3-month treatment period vs. 15.4% for placebo (P<0.001). Additionally, the 240mg group demonstrated a statistically significant improvement in physical function compared to placebo. 

“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,” said Christi Shaw, president of Lilly Bio-Medicines.

The Company is planning to submit a Biologics License Application to the Food and Drug Administration (FDA) for galcanezumab in the second half of 2017. 

For more information visit Lilly.com.