Drug updated on 10/25/2024
Dosage Form | Injection (intravenous; 400 mg/20 mL [20 mg/mL]) |
Drug Class | Neonatal Fc receptor blockers |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.
Latest News
Summary
- This summary is based on the review of one systematic review(s)/meta-analysis(es). [1]
- Rozanolixzumab and Batoclimab Effectiveness: Rozanolixzumab at doses of 7mg/kg and 10mg/kg showed superior effectiveness in improving MG-ADL scores compared to belimumab, efgartigimod (vyvgart), mezagitamab, and nipocalimab, with mean differences ranging from 2 to 3.69. Batoclimab at doses of 340mg and 680mg was more effective in improving QMG scores than placebo and other monoclonal antibodies, except rozanolixzumab, with mean differences ranging from 4.32 to 9.31.
- Efgartigimod Comparison: Efgartigimod (vyvgart) was less effective than rozanolixzumab in improving MG-ADL scores, with other monoclonal antibodies like belimumab, mezagitamab, and nipocalimab also showing lower effectiveness compared to rozanolixzumab.
- Belimumab demonstrated the most favorable safety profile with a significantly lower risk of adverse events compared to rozanolixzumab 7mg/kg (RR (Relative risk) 0.08, 95% CrI 0.01 to 0.94) and rozanolixzumab 10mg/kg (RR 0.08, 95% CrI 0.01 to 0.86).
- Rozanolixzumab was associated with a higher incidence of adverse events compared to belimumab, but specific adverse effects or comparative data for efgartigimod (vyvgart) were not detailed in the study.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Vyvgart (efgartigimod alfa-fcab) Prescribing Information. | 2024 | Argenx BV, Zwijnaarde, Belgium |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Efficacy and safety of the innovative monoclonal antibodies in adults with generalized myasthenia gravis: a Bayesian network analysis | 2023 | Frontiers in Immunology |