Drug updated on 9/4/2024
Dosage Form | Injection (subcutaneous; 70 mg/mL, 140 mg/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.
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Summary
- Aimovig (erenumab-aooe) is indicated for the preventive treatment of migraine in adults.
- This summary is based on the review of 26 systematic review(s)/meta-analysis(es). [1-26]
- Erenumab reduced mean monthly migraine days, with reductions of 1.1 days (28 mg), 1.4 days (70 mg), and 1.8 days (140 mg) compared to placebo in a meta-analysis.
- Systematic reviews confirmed that all anti-CGRP monoclonal antibodies, including Erenumab, significantly decreased mean monthly migraine days compared to placebo.
- Erenumab achieved higher rates of ≥50%, ≥75%, and 100% reduction in monthly migraine days from baseline, with significant improvements observed in multiple regions.
- Erenumab was effective in treating migraines with specific conditions, including allodynia, aura, prior preventive therapy failure, medication overuse headache, and menstrual migraine.
- Erenumab was more effective than placebo, though comparisons among anti-CGRP monoclonal antibodies indicated Fremanezumab and Galcanezumab had slightly higher efficacy in some analyses.
- The overall incidence of adverse events with Erenumab was comparable to placebo in most studies, with no significant differences in serious adverse events or treatment-emergent adverse events. Common adverse events reported included local skin reactions and constipation.
- Erenumab demonstrated a low incidence of serious adverse events, with pooled estimates indicating a 3% rate of serious adverse events and adverse events leading to discontinuation.
- Erenumab was generally well-tolerated compared to other anti-CGRP monoclonal antibodies and traditional prophylactic treatments, with fewer cognitive and sensory-related adverse events compared to topiramate and the lowest odds of any adverse events among anti-CGRP monoclonal antibodies in some analyses.
- A notable gender bias was observed with 85.1% of clinical trial participants being women; only two studies analyzed results by sex. Erenumab was effective in patients with prior treatment failures, reducing monthly migraine days and improving ≥50% response rates. Real-world data confirmed efficacy and safety in non-clinical settings, and favorable outcomes were observed when combined with other preventive drugs like Onabotulinumtoxin-A.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Aimovig (erenumab-aooe) Prescribing Information. | 2023 | Amgen Inc., Thousand Oaks, CA |