10.6084/m9.figshare.11919078.v1 Lesley Scott Lesley Scott Galcanezumab: a review in prevention of migraine and treatment of episodic cluster headache Adis Journals 2020 Galcanezumab Prevention of migraine treatment of episodic cluster headache review CGRP mononclonal antibody Adis Drug Evaluation 2020-06-07 20:28:10 Online resource https://adisjournals.figshare.com/articles/online_resource/Galcanezumab_a_review_in_prevention_of_migraine_and_treatment_of_episodic_cluster_headache/11919078 <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<sup>®</sup>) 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>