Galcanezumab: First Global Approval

Abstract

Galcanezumab-gnlm (Emgality™; Eli Lilly and Company), hereafter galcanezumab, is a humanized monoclonal antibody against the calcitonin gene-related peptide (CGRP) ligand. A potent vasodilator, CGRP is implicated in nociceptive transmission and migraine pathogenesis. In September 2018, the US FDA approved galcanezumab as a once-monthly subcutaneous injection for the preventive treatment of migraine in adults. In the same month, the EMA issued a positive opinion for galcanezumab for the prophylaxis of migraine in adults who have at least 4 migraine days per month. Galcanezumab is also undergoing phase III evaluation for the preventive treatment of cluster headache in North America and Europe. This article summarizes the milestones in the development of galcanezumab leading to its first approval for the preventive treatment of migraine in adults.