Drug updated on 9/4/2024
Dosage Form | Injection (subcutaneous; 100 mg/mL, 120 mg/mL) |
Drug Class | Calcitonin 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
- 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 Title | Year | Source |
---|---|---|
Emgality (galcanezumab-gnlm) Prescribing Information. | 2021 | Eli Lilly and Company, Indianapolis, IN |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
VA/DOD clinical practice guideline for management of headache. | 2023 | Department of Veterans Affairs Department of Defense |
European Headache Federation guideline on the use of monoclonal antibodies targeting the calcitonin gene related peptide pathway for migraine prevention – 2022 update. | 2022 | The Journal of Headache and Pain |
The American Headache Society Consensus Statement: Update on integrating new migraine treatments into clinical practice. | 2021 | Headache. The Journal of Head and Face Pain |
European headache federation guideline on the use of monoclonal antibodies acting on the calcitonin gene related peptide or its receptor for migraine prevention. | 2019 | The Journal of Headache and Pain |
The primary care management of headache: Synopsis of the 2020 U.S. Department of Veterans Affairs and U.S. Department of Defense clinical practice guideline. | 2019 | Military Medicine |