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Galcanezumab

(Emgality®)

Emgality®

Drug updated on 4/17/2024

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
This AI-generated content is provided without warranty and may be inaccurate or outdated; it should be used only as a research starting point, with no liability accepted for reliance on it. Learn more.

  • Galcanezumab (Emgality) is indicated in adults for the preventive treatment of migraine and episodic cluster headache.
  • A total of 20 systematic reviews/meta-analyses were reviewed to gather information about galcanezumab's safety and effectiveness compared to other drugs targeting the calcitonin gene-related peptide (CGRP) pathway.
  • In terms of safety, galcanezumab demonstrated a generally safe profile with larger odds of Treatment-emergent Adverse Events at a dosage of 240 mg but no significant differences in Serious Adverse Events when compared to placebo or other CGRP monoclonal antibodies such as erenumab, eptinezumab, fremanezumab, and gepants like atogepant and rimegepant.
  • Erenumab and fremanezumab showed lower odds of treatment discontinuation due to adverse events suggesting better tolerance than galcanezumab.
  • Regarding efficacy in preventing migraines, all interventions including galcanezumb significantly reduced Monthly Migraine Days while also showing higher responder rates especially for subcutaneous or intravenous administration routes.
  • Subgroup analysis highlighted that some chronic migraine patients might experience reduced efficacy towards the end of dosing interval with Galcanzeumb; however it was highly effective in reducing Monthly Migraine Days among patients who had previous treatment failures indicating its potential use cases where others have failed.
  • Amongst CGRP mAbs: Fremanezub stands out for its dosing flexibility & reduction acute medication days; Erenuman has lowest odds any adverse events & low rate discontinuation suggesting balance between efficacy tolerability; Eptinezuman greater odd adverse event leading discontinuation but lower TEAEs SAEs vs placebo can be important consideration.
  • Galcenezumb shows promising results both episodic chronic prevention despite noted AE @240mg dosage. Its effectiveness in sub-populations like those with chronic migraine exhibits its potential as a valuable option.

Product Monograph / Prescribing Information

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

Systematic Reviews / Meta-Analyses

Document TitleYearSource
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
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
Combined clinical and Pharmacoeconomic report: galcanezumab (Emgality).2021CADTH
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
Efficacy and safety of galcanezumab for preventive treatment of migraine: a systematic review and meta‑analysis. 2020Journal of Neurology
Galcanezumab for preventing migraine.2020NICE
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
Australian public assessment report for galcanezumab. 2019Australian Government: Department of Health
Calcitonin gene-related peptide (CGRP) inhibitors as preventive treatments for patients with episodic or chronic migraine: effectiveness and value.2018ICER

Clinical Practice Guidelines

Document TitleYearSource
European Headache Federation guideline on the use of monoclonal antibodies targeting the calcitonin gene related peptide pathway for migraine prevention – 2022 update. 2022The Journal of Headache and Pain
European headache federation guideline on the use of monoclonal antibodies acting on the calcitonin gene related peptide or its receptor for migraine prevention. 2019The Journal of Headache and Pain