Monthly, self administered injection could signal migraine breakthrough

Eli Lilly and Company announced that the FDA has accepted a Biologics License Application (BLA) to review galcanezumab for the prevention of migraine in adults. Galcanezumab has been submitted for use as a once-monthly, self-administered injection via auto-injector pen or prefilled syringe. Lilly announced the submission of the BLA on its third-quarter earnings call in October 2017.

The application includes positive data from three Phase III studies (EVOLVE-1, EVOLVE-2 and REGAIN), which evaluated 2,901 patients. In these studies, patients treated with galcanezumab experienced a statistically significantly greater decrease in the average number of monthly migraine headache days compared to placebo. The most commonly-reported adverse events were injection site reactions, including pain.

Galcanezumab represents the first of three investigational, non-opioid treatments in development as part of Lilly's overall pain portfolio. The portfolio also includes lasmiditan for the acute treatment of migraine and tanezumab, developed in partnership with Pfizer, for the treatment of osteoarthritis, chronic low back pain and cancer pain.