Migraine is a debilitating neurologic disease. People who experience migraine 
can have substantial disability, impaired functioning and a decreased quality of 
life (QoL). Expert recommendations suggest that people with frequent migraine 
attacks or severe impairment related to attacks may benefit from preventive 
treatment. Despite these recommendations and the existence of evidence-based 
guidelines for the use of preventive medication, many people who are candidates 
for preventive therapies do not receive them. Thus, there is still a substantial 
unmet need for preventive migraine treatment. Calcitonin gene-related peptide 
(CGRP) has a demonstrated role in the pathophysiology of migraine. 
Galcanezumab-gnlm (galcanezumab) is a humanized monoclonal antibody that binds 
to the CGRP ligand and prevents binding to its receptor. It is administered as a 
once-monthly subcutaneous injection. The aim of this review is to present a 
comprehensive overview of the existing short- and long-term efficacy and safety 
data for galcanezumab in patients with migraine. Data from the phase 3, 
randomized, double-blind, placebo-controlled EVOLVE-1, EVOLVE-2 and REGAIN 
studies show that galcanezumab treatment for 3 or 6 months results in overall 
reduction in mean monthly migraine headache days in patients with episodic 
(EVOLVE-1 and EVOLVE-2) and chronic (REGAIN) migraine. Greater proportions of 
patients with episodic migraine receiving galcanezumab versus placebo 
demonstrated a ≥ 50%, ≥ 75% and 100% response to therapy and reported a lower 
level of disability and an improvement in functioning and QoL. Similarly, when 
compared with placebo, greater proportions of patients with chronic migraine 
treated with galcanezumab demonstrated a ≥ 50% and ≥ 75% response and reported 
improved functioning. A 12-month open-label study demonstrated the continued 
efficacy of galcanezumab for up to 12 months. In all studies galcanezumab was 
well tolerated. In conclusion, data from pivotal studies show that galcanezumab 
may fulfill an unmet need in the treatment of patients with migraine who require 
preventive therapy.