Galcanezumab: a review in prevention of migraine and treatment of episodic cluster headache

<p><b>Compliance with Ethical Standards</b></p> <p><b>Funding</b> The preparation of this review was not supported by any external funding.</p> <b>Conflict of interest<i> </i></b>Lesley Scott is a salaried employee of Adis International Ltd/Springer Nature, is responsible for the article content and declares no relevant conflicts of interest.<div><br></div><div>Additional information about this Adis Drug Review can be found here<br></div><div><br></div><div>Abstract</div><div><p></p><p>Galcanezumab (Emgality^®) is a humanized monoclonal antibody targeting the calcitonin gene-related peptide (CGRP), thereby inhibiting its physiological activity, with CGRP playing a key role in the pathophysiology of migraine and headache disorders. In pivotal phase 3 trials, recommended dosages of subcutaneous galcanezumab once monthly were significantly more effective than placebo as preventive therapy in adults with episodic (EVOLVE-1 and -2; over 6 months) or chronic (REGAIN; over 3 months) migraine (± aura), including in patients who had failed several prior preventive migraine drugs (CONQUER; over 3 months). The beneficial effects of galcanezumab preventive treatment in reducing the number of monthly migraine headache days (MHDs) and improving health-related quality of life (HR-QOL) were sustained during up to 1 year of treatment. In adults with episodic cluster headache, galcanezumab treatment was associated with a significant reduction in the weekly frequency of cluster headache attacks across weeks 1–3 compared with placebo (primary endpoint), albeit during weeks 4 to 8, there was a convergence of results between these treatment groups. Although further evidence from the clinical setting is required to determine its long-term safety profile, given its convenient administration regimen, efficacy and short-term tolerability profile, monthly galcanezumab represents an important emerging option for the prevention of episodic and chronic migraine (± aura) and the treatment of episodic cluster headache. </p><p><br></p><p>© Springer Nature Switzerland AG 2020</p><br></div>