FDA Accepts Lilly’s Application for Migraine Biologic

FDA has accepted a biologics license application (BLA) from Eli Lilly and Company to review galcanezumab, a monoclonal antibody (mAb) being developed to prevent migraine in adults, Lilly announced on Dec. 11, 2017. The biologic has been submitted for use as a once-monthly, self-administered injection in an auto-injector pen or prefilled syringe. Lilly announced the submission of the BLA in its third-quarter earnings call in October 2017.

Galcanezumab is 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. It is a part of Lilly’s pain portfolio and represents the first of three investigational, non-opioid treatments in development by the company. The portfolio also includes lasmiditan, for the acute treatment of migraine, and tanezumab, developed in partnership with Pfizer, for treating osteoarthritis, chronic low back pain, and cancer pain.