Galcanezumab: A Review in the Prevention of Migraine and Treatment of Episodic Cluster Headache
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ADIS DRUG EVALUATION
Galcanezumab: A Review in the Prevention of Migraine and Treatment of Episodic Cluster Headache Lesley J. Scott1
© Springer Nature Switzerland AG 2020
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.
Galcanezumab: clinical considerations in the prevention of migraine and treatment of episodic cluster headache Humanized monoclonal antibody targeting the CGRP peptide, thereby inhibiting its physiological activity in pain pathways Reduces monthly MHDs and improves HR-QOL (vs placebo) as preventive therapy for migraine (± aura); benefits sustained with longer-term use 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.
Reduces weekly frequency of episodic cluster headache attacks across weeks 1–3 (vs placebo) Generally well tolerated
* Lesley J. Scott [email protected] 1
Springer Nature, Private Bag 65901, Mairangi Bay, Auckland 0754, New Zealand Vol.:(0123456789)
L. J. Scott
1 Introduction Migraine and cluster headache are debilitating neurological disorders that have a significant impact on healthrelated quality of life (HR-QOL) and impose a considerable burden from a societal (impacts a patient’s physical, social and occupational functioning, and associated with lost productivity) and healthpaye
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