Galcanezumab-gnlm

(Emgality®)

Galcanezumab-gnlm

Drug updated on 9/4/2024

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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  • Emgality (galcanezumab-gnlm) is indicated in adults for the preventive treatment of migraine and the treatment of episodic cluster headache.
  • This summary is based on the review of 23 systematic review(s)/meta-analysis(es). [1-23]
  • Reduction in Monthly Migraine Days (MMDs): Galcanezumab significantly reduced MMDs, with reductions of 1.98 days (120 mg) and 1.86 days (240 mg) compared to placebo. It showed comparable or superior effectiveness to other anti-CGRP antibodies.
  • Responder Rate (≥50% Reduction in Migraine Days): Galcanezumab achieved a 54% responder rate for reducing migraine days by at least 50%, similar to other anti-CGRP antibodies.
  • Transition from Medication Overuse (MO) or Medication Overuse Headache (MOH): Galcanezumab was statistically significant in transitioning patients from MO or MOH to non-MO status, with a relative risk (RR) of 1.44, compared to a higher RR of 1.71 in the Tripan group.
  • Effectiveness in Episodic and Chronic Migraine: Galcanezumab was effective in reducing monthly migraine days and headache days in both episodic and chronic migraine, with similar effectiveness to other anti-CGRP antibodies.
  • Adverse Events (AEs): Galcanezumab was associated with mild to moderate AEs, including injection-site pain and nasopharyngitis, with a safety profile similar to placebo and comparable to other anti-CGRP antibodies like erenumab and fremanezumab.
  • Serious Adverse Events (SAEs): Galcanezumab did not significantly increase the incidence of SAEs compared to placebo, with similar observations noted for other anti-CGRP antibodies.
  • Treatment-Emergent Adverse Events (TEAEs): Galcanezumab showed higher odds of TEAEs (OR 1.63) compared to placebo; however, eptinezumab 30 mg had the lowest odds, and atogepant 120 mg had the highest odds of TEAEs among the compared treatments.
  • There is no population types or subgroups information available in the reviewed studies.

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
CGRP, a target for preventive therapy in migraine and cluster headache: systematic review of clinical data. 2019Cephalalgia

Clinical Practice Guidelines