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.
Keywords: CGRP antagonists; Chronic migraine; Episodic migraine; Galcanezumab; Migraine; Migraine prevention.
Migraine is a significant contributor to the global burden of disease. Migraine symptoms can lead to substantial disability and can significantly impact an individual’s ability to perform everyday tasks and their overall quality of life. While individuals with infrequent migraine attacks might have success with acute treatments alone, those with more frequent attacks or who have severe migraine-related impairment may require preventive treatment. Although recommendations on the use of preventive treatment exist, only about one-third of individuals who qualify for preventive therapy actually receive it, resulting in a substantial unmet need. Calcitonin gene-related peptide (CGRP) has a demonstrated role in migraine. Galcanezumab is a humanized monoclonal antibody that binds to the CGRP ligand and prevents receptor binding. In clinical trials of patients with ≥ 4 migraine headache days per month, treatment with galcanezumab was associated with a reduction in the average number of migraine headache days per month. The majority of galcanezumab groups had greater responder rates compared with the placebo groups, and levels of disability and daily functioning were generally improved. Galcanezumab was well tolerated, with the most common adverse events being injection site reactions. The results from the clinical trials of galcanezumab suggest that this drug may fulfill an unmet need in the treatment of individuals with migraine who require preventive therapy.