FDA Accepts Lilly’s Application for Migraine Biologic
FDA has accepted for review Eli Lilly and Company’s biologic drug candidate that is in development for treating migraine.
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.
Source: Eli Lilly and Company
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
