Fremanezumab-vfrm

(Ajovy®)

Ajovy®

Drug updated on 10/29/2024

Dosage FormInjection (subcutaneous; 225 mg/1.5 mL)
Drug ClassCalcitonin gene-related peptide receptor antagonists
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the preventive treatment of migraine in adults.

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Summary
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  • This summary is based on the review of 25 systematic review(s)/meta-analysis(es). [1-25]
  • Fremanezumab significantly reduced monthly migraine days, with a mean difference of -2.77 days (95% CrI: -3.36 to -2.17) in chronic migraine, and was ranked highest for this outcome with a 0.98 probability.
  • The 50% response rate for fremanezumab 225 mg monthly was high, with a risk ratio of 2.98 (95% CI: 2.16, 4.10), and it showed significant reductions in disability, achieving higher proportions of ≥50% reductions in MIDAS (n = 234) scores compared to placebo.
  • Fremanezumab demonstrated effectiveness across both chronic and episodic migraine populations, with 225 mg monthly particularly effective in chronic migraine cases.
  • Real-world studies supported fremanezumab’s effectiveness as observed in RCTs, though these studies were limited by retrospective data collection and small patient numbers.
  • Fremanezumab had a generally mild safety profile, with adverse events such as general disorders and administration site conditions comparable to placebo, and no significant differences in treatment discontinuation due to adverse events.
  • Cardiovascular and cerebrovascular adverse events were infrequent and occurred at similar rates between fremanezumab and placebo groups, with no significant cardiovascular safety concerns identified.
  • The number and type of adverse events reported did not significantly differ between the fremanezumab-treated and placebo groups, further supporting its favorable safety profile.
  • Fremanezumab was effective across various subgroups, including patients with chronic and episodic migraine, with 85.1% of trial participants being women. It also showed significant efficacy in patients with prior treatment failures, and it was safe and well-tolerated in individuals with cardiovascular risk factors.

Product Monograph / Prescribing Information

Document TitleYearSource
Ajovy (fremanezumab-vfrm) Prescribing Information.2022Teva Pharmaceuticals USA, Inc., Parsippany, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
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
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
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
Monoclonal Antibodies against Calcitonin Gene-Related Peptide for Migraine Prophylaxis: A Systematic Review of Real-World Data2022Cells
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
Impact of fremanezumab on disability outcomes in patients with episodic and chronic migraine: a pooled analysis of phase 3 studies2022The Journal of Headache and Pain
Treatment of resistant chronic migraine with anti-CGRP monoclonal antibodies: a systematic review2022European Journal of Medical Research
Safety and tolerability of fremanezumab in patients with episodic and chronic migraine: a pooled analysis of phase 3 studies2022Cephalalgia
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
Anti-CGRP monoclonal antibodies for migraine prevention: A systematic review and likelihood to help or harm analysis2021Cephalalgia
Monthly versus quarterly fremanezumab for the prevention of migraine: a systemic review and meta-analysis from randomized controlled trials2021Naunyn-Schmiedeberg's Archives of Pharmacology
Optimal treatment strategy of fremanezumab in migraine prevention: a systematic review with network meta-analysis of randomized clinical trials2020Scientific Reports
Safety and Efficacy of Fremanezumab for the Prevention of Migraine: A Meta-Analysis From Randomized Controlled Trials2020Frontiers in Neurology
Monoclonal antibodies as a preventive therapy for migraine: A meta-analysis2020Clinical Neurology and Neurosurgery
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

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