Efgartigimod alfa-fcab

(Vyvgart®)

Efgartigimod alfa-fcab

Drug updated on 12/11/2024

Dosage FormInjection (intravenous; 400 mg/20 mL [20 mg/mL])
Drug ClassNeonatal 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.

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Summary
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  • This summary is based on the review of one systematic review/meta-analysis. [1]
  • Rozanolixzumab and Batoclimab Effectiveness: Rozanolixzumab at doses of 7mg/kg and 10mg/kg showed superior effectiveness in improving the Myasthenia Gravis Activities of Daily Living (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 the Quantitative Myasthenia Gravis Score (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 (relative risk (RR) 0.08, 95% credible interval (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 TitleYearSource
Vyvgart (efgartigimod alfa-fcab) Prescribing Information.2024Argenx BV, Zwijnaarde, Belgium

Systematic Reviews / Meta-Analyses