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Galcanezumab: A Review in the Prevention of Migraine and Treatment of Episodic Cluster Headache

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A Correction to this article was published on 25 July 2020

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Abstract

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 4–8, 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.

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Change history

  • 25 July 2020

    The name of the first reviewer which previously read.

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Acknowledgements

During the peer review process, the manufacturer of galcanezumab was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

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    Lesley J. Scott

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Correspondence to Lesley J. Scott.

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The preparation of this review was not supported by any external funding.

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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.

Additional information

Enhanced material for this Adis Drug Evaluation can be found at 10.684/m9.figshare.11919078.

The manuscript was reviewed by: J. R. Crouch Jr, Department of Neurology, University of Oklahoma Medical School, Oklahoma City, OK, USA; A. V. Krymchantowski, Headache Center of Rio, Rio de Janeiro, Brazil; K. C. Maasumi, University of California San Francisco, San Francisco, CA, USA.

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Scott, L.J. Galcanezumab: A Review in the Prevention of Migraine and Treatment of Episodic Cluster Headache. Drugs 80, 893–904 (2020). https://doi.org/10.1007/s40265-020-01329-5

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