FDA will review Eli Lilly’s Galcanezumab for the prevention of migraine in adults

Eli Lilly said on Monday that the U.S. Food and Drug Administration (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 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.

“Migraine is more than a headache. It is a debilitating disease affecting one in eight Americans and may cause days of lost productivity each month,” said Christi Shaw, president of Lilly Bio-Medicines. “We have worked for more than 25 years to develop innovative migraine therapies, and we are truly pleased to be one step closer to potentially providing a new self-administered and effective preventive treatment option that may help people experience fewer migraine days.”

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.