Efgartigimod alfa-fcab

(Vyvgart®)

Vyvgart®

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Drug updated on 5/17/2024

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.

Summary
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  • 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 TitleYearSource
Vyvgart (efgartigimod alfa-fcab) Prescribing Information.2024argenx BV, Zwijnaarde, Belgium

Systematic Reviews / Meta-Analyses