FDA Accepts BLA to Review Galcanezumab for Migraine

Eli Lilly and Company announced 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.

Galcanezumab is a monoclonal antibody specifically designed to bind to and inhibit the activity of calcitonin gene-related peptide (CGRP), which is believed to play a role in migraine and cluster headache. Galcanezumab is an investigational once-monthly, self-administered injection under evaluation for the prevention of migraine and cluster headache.

Migraine is a disabling neurological disease characterized by recurrent episodes of severe headache accompanied by other symptoms including nausea, vomiting, sensitivity to light and sound, and changes in vision. More than 36 million Americans have migraine, with three times more women affected by migraine compared to men.  According to the Migraine Research Foundation, healthcare and lost productivity costs associated with migraine are estimated to be as high as $36 billion annually in the United States.