Lilly Plans BLA for Migraine Biologic Therapy

Eli Lilly says it will file a BLA in the second half of this year after reporting positive Phase 3 data for galcanezumab, an investigational treatment for preventing episodic and chronic migraines. Three Phase 3 studies (EVOLVE-1, EVOLVE-2 and REGAIN) demonstrated “statistically significant reductions in the number of monthly migraine headache days compared to placebo at both studied doses,” the company says. “In these three studies, the most commonly-reported adverse events were injection site reactions, including pain. The observed safety and tolerability profile was consistent with findings from previous studies of galcanezumab.”

Galcanezumab is a monoclonal antibody designed to bind to and inhibit the activity of calcitonin gene-related peptide, which is believed to play a role in migraine and cluster headaches, Lilly says. It is intended to be a once-monthly, self-administered injection.