Posted by Michael Wonder on 11 Dec 2017
Galcanezumab is the first of three investigational, non-opioid treatments in Lilly's pain portfolio
11 December 2017 - Eli Lilly announced today that the U.S.FDA has accepted a biologics license application 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 pre-filled syringe.
Lilly announced the submission on its third-quarter earnings call in October 2017.
The application includes positive data from three Phase 3 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.
