Galcanezumab-gnlm

(Emgality®)

Emgality®

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Drug updated on 5/17/2024

Dosage FormInjection (subcutaneous; 100 mg/mL, 120 mg/mL)
Drug ClassCalcitonin gene-related peptide antagonists
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated in adults for the preventive treatment of migraine.
  • Indicated in adults for the treatment of episodic cluster headache.

Summary
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  • Galcanezumab-gnlm (Emgality) is indicated for the prevention of migraine and the treatment of episodic cluster headaches in adults. It targets and inhibits the action of calcitonin gene-related peptide, a protein implicated in migraine pathophysiology.
  • A comprehensive review was conducted on 23 systematic reviews/meta-analyses focusing on the safety and effectiveness of Emgality within migraine and episodic cluster headache treatment contexts.
  • Galcanezumab consistently demonstrates significant reductions in monthly migraine days (MMDs) and the frequency of episodic cluster headaches compared to placebo. Doses typically range between 120mg to 240mg subcutaneously.
  • When directly compared with other CGRP-targeting monoclonal antibodies such as erenumab, fremanezumab, or eptinezumab, galcanezumab often ranks high for reducing MMDs while maintaining a favorable responder rate over 50%.
  • The drug has been found to be well-tolerated with the most common adverse events being injection-site reactions, nasopharyngitis, and upper respiratory tract infections, which are generally of mild to moderate severity. The incidence of serious adverse events is low and comparable to placebo groups.
  • Galcanezumab significantly aids in reversing medication overuse status among patients suffering from chronic migraines, highlighting its role in managing this condition effectively.
  • Studies suggest superior efficacy even among difficult-to-treat populations who have had prior treatment failures, making it a valuable option for these patients as well.
  • As one of the few treatments specifically indicated for episodic cluster headaches, galcanezumab outperforms traditional therapies like verapamil by providing significant relief through a reduction in headache frequency.

Product Monograph / Prescribing Information

Document TitleYearSource
Emgality (galcanezumab-gnlm) Prescribing Information.2021Eli Lilly and Company, Indianapolis, IN

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Reporting quality and risk of bias analysis of published RCTs assessing anti-CGRP monoclonal antibodies in migraine prophylaxis: a systematic review.2024Journal of Clinical Medicine
The transition of medication overuse status by acute medication categories in episodic or chronic migraine patients to non-overuse status after receiving anti-CGRP monoclonal antibodies: a systematic review and meta-analysis of phase 3 randomized control trial.2024Neurological Sciences
Safety and tolerability of monoclonal antibodies targeting the CGRP pathway and gepants in migraine prevention: a systematic review and network meta-analysis.2023Cephalagia
Evaluating the efficacy of CGRP mAbs and gepants for the preventive treatment of migraine: a systematic review and network meta-analysis of phase 3 randomised controlled trials.2023Cephalagia
Efficacy and safety of anti-calcitonin gene-related peptide (CGRP) monoclonal antibodies in preventing migraines: a systematic review.2023Cureus
Effectiveness of calcitonin gene-related peptide monoclonal antibodies in the prevention of migraine: a systematic review and meta-analysis of observational cohort studies.2023Clinical Drug Investigation
Comparative efficacy and safety of five anti-calcitonin gene-related peptide agents for migraine prevention: a network meta-analysis.2023The Clinical Journal of Pain
"Wearing-off" efficacy of CGRP monoclonal antibodies for migraine prevention: a meta-analysis of randomized controlled trials. 2023Cephalalgia
Clinical effectiveness of pharmacological interventions for managing chronic migraine in adults: a systematic review and network meta-analysis.2023Journal of Headache and Pain
Efficacy and safety of monoclonal antibody against calcitonin gene-related peptide or its receptor for migraine patients with prior preventive treatment failure: a network meta-analysis.2022The Journal of Headache and Pain
Treatment of resistant chronic migraine with anti-CGRP monoclonal antibodies: a systematic review.2022European Journal of Medical Research
A systematic review of economic evaluations of pharmacological treatments for adults with chronic migraine.2022The Journal of Headache and Pain
Efficacy and safety of galcanezumab for preventive treatment of migraine: a systematic review and meta‑analysis. 2021Journal of Neurology
Efficacy and safety of monoclonal antibody against calcitonin gene-related peptide or its receptor for migraine: a systematic review and network meta-analysis. 2021Frontiers in Pharmacology
Anti-CGRP monoclonal antibodies for migraine prevention: a systematic review and likelihood to help or harm analysis. 2021Cephalalgia
Efficacy of calcitonin gene-related peptide (CGRP) receptor blockers in reducing the number of monthly migraine headache days (MHDs): a network meta-analysis of randomized controlled trials. 2021Journal of Neurology
Systematic literature review and Bayesian network meta-analysis of episodic cluster headache drugs. 2021European Review for Medical and Pharmacological Science
Calcitonin gene-related peptide monoclonal antibodies versus botulinum neurotoxin A in the preventive treatment of chronic migraine: an adjusted indirect treatment comparison meta-analysis. 2021Frontiers in Pharmacology
Efficacy and safety of anti-calcitonin gene-related peptide monoclonal antibodies for treatment of chronic migraine: a systematic review and network meta-analysis.2021Clinical Neurology and Neurosurgery
Galcanezumab in migraine prevention: a systematic review and meta-analysis of randomized controlled trials. 2020Therapeutic Advances in Neurological Disorders
Efficacy and safety of calcitonin-gene-related peptide binding monoclonal antibodies for the preventive treatment of episodic migraine - an updated systematic review and meta-analysis. 2020BMC Neurology
Galcanezumab for the management of migraine: a systematic review and meta-analysis of randomized placebo-controlled trials.2020Cureus
Assessment report: Emgality. 2020EMA
CGRP, a target for preventive therapy in migraine and cluster headache: systematic review of clinical data. 2019Cephalalgia

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