Galcanezumab-gnlm

(Emgality®)

Galcanezumab-gnlm

Drug updated on 12/11/2024

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.

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Summary
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  • This summary is based on the review of 35 systematic review(s)/meta-analysis(es). [1-35]
  • Reduction in Monthly Migraine Days (MMDs): Galcanezumab reduced MMDs by -2.02 days compared to placebo (mean difference (MD) -2.02, 95% credible interval (CrI) -2.62 to -1.42), while fremanezumab showed a higher reduction with -2.77 days (95% CrI -3.36 to -2.17). Eptinezumab reduced monthly headache days by -2.46 days (95% CrI: -3.23 to -1.69).
  • Responder Rates: Fremanezumab demonstrated the highest 50% response rate in reducing MMDs, with a risk ratio of 2.98 (95% confidence interval (CI): 2.16, 4.10), while galcanezumab also showed a significant response in achieving ≥50% reduction in MMDs across various doses.
  • Quality of Life Improvements: Galcanezumab significantly improved patient-reported outcomes, including the migraine-specific quality of life role function-restrictive domain (MSQ RF-R) and migraine disability assessment (MIDAS) scores.
  • Comparative Effectiveness: Fremanezumab and eptinezumab often outperformed galcanezumab in specific outcomes. Galcanezumab was more effective than triptans like sumatriptan in reducing headache days but was surpassed by fremanezumab in some studies.
  • General Safety: Galcanezumab demonstrated a generally favorable safety profile, with common adverse events (AEs) including injection-site pain, nasopharyngitis, and upper respiratory tract infections. Fremanezumab had higher rates of injection-site reactions but was still considered safe overall.
  • Comparison to Placebo: Galcanezumab showed a slight increase in treatment-emergent adverse events (TEAEs) compared to placebo (RR 1.11, 95% CrI 1.01-1.22), but no significant differences in serious adverse events were observed between galcanezumab and placebo.
  • Comparative Safety: Galcanezumab and fremanezumab had similar safety profiles, though fremanezumab had more frequent injection-site reactions. Galcanezumab had a slightly higher incidence of AEs compared to erenumab.
  • Galcanezumab was particularly effective in chronic migraine patients, showing significant reductions in monthly migraine days (MMDs) and headache days. Although 85.1% of study participants were women, no conclusive gender-specific effectiveness data were reported. Additionally, galcanezumab demonstrated effectiveness in treatment-resistant chronic migraine patients, though some experienced a wearing-off effect over time.

Product Monograph / Prescribing Information

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

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Acute and preventive treatment of menstrual migraine: a meta-analysis2024The Journal of Headache and Pain
Adverse and serious adverse events incidence of pharmacological interventions for managing chronic and episodic migraine in adults: a systematic review2024BMJ Neurology Open
Reporting Quality and Risk of Bias Analysis of Published RCTs Assessing Anti-CGRP Monoclonal Antibodies in Migraine Prophylaxis: A Systematic Review2024Journal of Clinical Medicine
Clinical effectiveness of pharmacological interventions for managing chronic migraine in adults: a systematic review and network meta-analysis2023The Journal of Headache and Pain
Competing treatments for migraine: a headache for decision-makers2023The Journal of Headache and Pain
Efficacy and Safety of Anti-calcitonin Gene-Related Peptide (CGRP) Monoclonal Antibodies in Preventing Migraines: A Systematic Review2023Cureus
Comparative Efficacy and Safety of Five Anti-calcitonin Gene-related Peptide Agents for Migraine Prevention: A Network Meta-analysis2023The Clinical Journal of Pain
Gender bias in clinical trials of biological agents for migraine: A systematic review2023PLoS One
"Wearing-off" efficacy of CGRP monoclonal antibodies for migraine prevention: A meta-analysis of randomized controlled trials2023Cephalalgia
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 trials2023Cephalalgia
Safety and tolerability of monoclonal antibodies targeting the CGRP pathway and gepants in migraine prevention: A systematic review and network meta-analysis2023Cephalalgia
Effectiveness and Safety of Chronic Migraine Preventive Treatments: A Systematic Literature Review2023Pain and Therapy
Efficacy and safety of galcanezumab for migraine: evidences from direct and indirect comparisons2023The International Journal of Neuroscience
Monoclonal Antibodies against Calcitonin Gene-Related Peptide for Migraine Prophylaxis: A Systematic Review of Real-World Data2022Cells
A systematic review of economic evaluations of pharmacological treatments for adults with chronic migraine2022The Journal 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-analysis2022The Journal of Headache and Pain
European Headache Federation guideline on the use of monoclonal antibodies targeting the calcitonin gene related peptide pathway for migraine prevention - 2022 update2022The Journal of Headache and Pain
Treatment of resistant chronic migraine with anti-CGRP monoclonal antibodies: a systematic review2022European Journal of Medical Research
Comparative Effectiveness and Tolerability of the Pharmacology of Monoclonal Antibodies Targeting the Calcitonin Gene-Related Peptide and Its Receptor for the Prevention of Chronic Migraine: a Network Meta-analysis of Randomized Controlled Trials2021Neurotherapeutics
Efficacy and safety of anti-calcitonin gene-related peptide monoclonal antibodies for treatment of chronic migraine: A systematic review and network meta-analysis2021Clinical Neurology and Neurosurgery
Quality of Life Related to Functional Disability in Migraine Patients: A Systematic Review and Network Meta-analysis2021The Clinical Journal of Pain
Network meta-analysis on efficacy and safety of different anti-CGRP monoclonal antibody regimens for prophylaxis and treatment of episodic migraine2021Neurological Research
Indirect Comparison of Topiramate and Monoclonal Antibodies Against CGRP or Its Receptor for the Prophylaxis of Episodic Migraine: A Systematic Review with Meta-Analysis2021CNS Drugs
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 trials2021Journal of the Neurological Sciences
Efficacy and Safety of Monoclonal Antibody Against Calcitonin Gene-Related Peptide or Its Receptor for Migraine: A Systematic Review and Network Meta-analysis2021Frontiers in Pharmacology
Systematic literature review and Bayesian network meta-analysis of episodic cluster headache drugs2021European Review for Medical and Pharmacological Sciences
Efficacy and safety of galcanezumab for preventive treatment of migraine: a systematic review and meta-analysis2021Journal of Neurology
Anti-CGRP monoclonal antibodies for migraine prevention: A systematic review and likelihood to help or harm analysis2021Cephalalgia
Efficacy and safety of galcanezumab for preventive treatment of migraine: a systematic review and meta-analysis2021Journal of Neurology
Galcanezumab for the Management of Migraine: A Systematic Review and Meta-Analysis of Randomized Placebo-Controlled Trials2020Cureus
Monoclonal antibodies as a preventive therapy for migraine: A meta-analysis2020Clinical Neurology and Neurosurgery
Galcanezumab in migraine prevention: a systematic review and meta-analysis of randomized controlled trials2020Therapeutic 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-analysis2020BMC Neurology
Different doses of galcanezumab versus placebo in patients with migraine and cluster headache: a meta-analysis of randomized controlled trials2020The Journal of Headache and Pain
The treatment efficacy of galcanezumab for migraine: A meta-analysis of randomized controlled trials2019Clinical Neurology and Neurosurgery

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