Fremanezumab-vfrm

(Ajovy®)

Ajovy®

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Drug updated on 5/17/2024

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.

Summary
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  • Fremanezumab-vfrm (Ajovy) is a monoclonal antibody targeting the calcitonin gene-related peptide pathway, approved for the preventive treatment of migraine in adults. It consistently shows a significant reduction in monthly migraine days and high rates of achieving at least a 50% reduction.
  • The analysis was based on 28 studies that focused on aspects such as Ajovy's efficacy, safety, comparisons with other drugs, population, and subgroup considerations related to migraine prevention.
  • Ajovy appears equally effective in episodic and chronic migraine subgroups. Certain dosing regimens offer optimal balances of efficacy and safety. It also proves effective for patients with medication-overuse headache (MOH) or those who had inadequate responses to other preventative measures like topiramate or BOTOX.
  • In terms of safety profile, most adverse events associated with Ajovy are of mild to moderate severity, similar to placebo effects observed during clinical trials; injection site reactions being the most common adverse event reported.
  • Long-term data suggests a good tolerability profile without any new identified safety signals over extended periods, making it safe for long-term use among adult patients suffering from migraines.
  • When compared against other CGRP monoclonal antibodies like erenumab, galcanezumab, and eptinezumab; fremanezumab exhibits comparable efficacy and safety profiles, suggesting no significant difference between these treatments regarding reducing migraines or their respective side effects.
  • Compared against oral preventatives such as topiramate and propranolol; fremanezumab has shown advantages by having higher likelihood-to-help-versus-harm values indicating its superior benefit-risk ratio, which makes it a more favorable option than traditional oral medications used for preventing migraines.
  • Ajovy's effectiveness does not significantly vary between chronic versus episodic sufferers, making it a versatile preventative option across different types of migraines, irrespective of the gender bias prevalent within clinical trial recruitment and analysis.

Product Monograph / Prescribing Information

Document TitleYearSource
Ajovy (fremanezumab-vfrm) Prescribing Information.2022Teva Pharmaceuticals USA, North Wales, PA

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
Clinical effectiveness of pharmacological interventions for managing chronic migraine in adults: a systematic review and network meta-analysis.2023The Journal of Headache and Pain
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
Safety and tolerability of monoclonal antibodies targeting the CGRP pathway and gepants in migraine prevention: a systematic review and network meta-analysis.2023Cephalalgia
Effectiveness and safety of chronic migraine preventive treatments: a systematic literature review.2023Pain and Therapy
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.2023Cephalalgia
Gender bias in clinical trials of biological agents for migraine: a systematic review.2023PLoS One
Comparative efficacy and safety of five anti-calcitonin gene-related peptide agents for migraine prevention: a network meta-analysis.2023Clinical Journal of Pain
Methodological considerations on real-world evidence studies of monoclonal antibodies against the CGRP-pathway for migraine: a systematic review. 2023The Journal of Headache and Pain
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 trials.2022Neurotherapeutics
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
Monoclonal antibodies against calcitonin gene-related peptide for migraine prophylaxis: a systematic review of real-world data.2022Cells
Monthly versus quarterly fremanezumab for the prevention of migraine: a systemic review and meta-analysis from randomized controlled trials. 2021Naunyn-Schmiedeberg's Archives of Pharmacology
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 the Neurological Sciences
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 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
Calcitonin gene–related peptide monoclonal antibody versus botulinum toxin for the preventive treatment of chronic migraine: evidence from indirect treatment comparison. 2021Frontiers in Pharmacology
Indirect comparison of topiramate and monoclonal antibodies against CGRP or its receptor for the prophylaxis of episodic migraine: a systematic review with meta-analysis.2021CNS Drugs
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
Quality of life related to functional disability in migraine patients: a systematic review and network meta-analysis.2021The Clinical Journal of Pain
Safety and efficacy of fremanezumab for the prevention of migraine: a meta-analysis from randomized controlled trials.2020Frontiers in Neurology
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
Optimal treatment strategy of fremanezumab in migraine prevention: a systematic review with network meta‑analysis of randomized clinical trials. 2020Scientific Reports
Monoclonal antibodies against calcitonin gene-related peptide in chronic migraine: an adjusted indirect treatment comparison. 2020Farmacia Hospitalaria
CGRP, a target for preventive therapy in migraine and cluster headache: systematic review of clinical data. 2019Cephalalgia

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