Drug updated on 12/11/2024
Dosage Form | Injection (subcutaneous; 225 mg/1.5 mL) |
Drug Class | Calcitonin gene-related peptide receptor antagonists |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the preventive treatment of migraine in adults.
Latest News
Summary
- 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% credible intrval (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% confidence interval (CI): 2.16, 4.10), and it showed significant reductions in disability, achieving higher proportions of ≥50% reductions in Migraine Disability Assessment (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 randomized controlled trials (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 Title | Year | Source |
---|---|---|
Ajovy (fremanezumab-vfrm) Prescribing Information. | 2022 | Teva Pharmaceuticals USA, Inc., Parsippany, NJ |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
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 primary care management of headache: synopsis of the 2020 U.S. department of veterans affairs and U.S. department of defense clinical practice guideline. | 2022 | Military Medicine |
The American Headache Society Consensus Statement: Update on integrating new migraine treatments into clinical practice. | 2021 | Headache |
VA/DoD clinical practice guideline for management of headache. | Department of Veterans Affairs Department of Defense |