Drug updated on 5/17/2024
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
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Summary
- Efgartigimod alfa-fcab (Vyvgart) is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.
- Two studies assessed and compared the safety and efficacy of efgartigimod with other monoclonal antibodies in treating gMG.
- The studies suggest that efgartigimod has a notable effect on improving the Quantitative Myasthenia Gravis scale score, indicating strong short-term efficacy against placebo when compared to complement inhibitors.
- Other medications such as Rozanolixizumab and Batoclimab were identified as potentially effective treatments for gMG based on MG Activities of Daily Living scores. However, Rituximab did not significantly improve these scores, suggesting it may be less effective than both complement inhibitors and anti-FcRn treatments like efgartigimod.
- In terms of safety profile comparison, Belimumab demonstrated a higher safety profile with fewer adverse events compared to Rozanolixizumab.
- While these studies primarily focused on adult patients with gMG who are AChR antibody positive, detailed subgroup analysis or specific population considerations were not discussed.
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 of innovative therapies in myasthenia gravis: a systematic review, meta-analysis and network meta-analysis. | 2023 | European Journal of Neurology |
Efficacy and safety of the innovative monoclonal antibodies in adults with generalized myasthenia gravis: a Bayesian network analysis. | 2023 | Frontiers in Immunology |