The U.S. Food and Drug Administration accepted Eli Lilly and Co.'s Biologics License Application to review galcanezumab for the prevention of migraine in adults.
The application includes results from three phase 3 studies, where the medicine showed a statistically significant decrease in the average number of monthly migraine headache days compared to placebo.
Galcanezumab is submitted for use as a once-monthly, self-administered injection via auto-injector pen or prefilled syringe.
Galcanezumab represents the first of three investigational, nonopioid treatments being developed as part of Eli Lilly's overall pain portfolio. The portfolio also includes lasmiditan for the acute treatment of migraine and tanezumab, developed in partnership with Pfizer Inc., for the treatment of osteoarthritis, chronic low back pain and cancer pain.