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Vyvgart FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 10, 2022.

FDA Approved: Yes (First approved December 17, 2021)
Brand name: Vyvgart
Generic name: efgartigimod alfa-fcab
Dosage form: Injection
Company: argenx SE
Treatment for: Myasthenia Gravis

Vyvgart (efgartigimod alfa-fcab) is a neonatal Fc receptor blocker indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.

  • Generalized myasthenia gravis is a rare and chronic autoimmune disease where IgG autoantibodies disrupt communication between nerves and muscles, causing debilitating and potentially life-threatening muscle weakness. Vyvgart works by binding to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG.
  • FDA approval is based on results from the global Phase 3 ADAPT trial which demonstrated that significantly more anti-AChR antibody positive gMG patients were responders on the MG-ADL (Myasthenia Gravis Activities of Daily Living Profile) scale following treatment with Vyvgart compared with placebo (68% vs. 30%; p<0.0001).
  • Vyvgart is administered as an intravenous infusion over one hour once weekly for 4 weeks.
  • Vyvgart may cause serious adverse reactions including hypersensitivity reactions. Common adverse reactions include respiratory tract infections, headache, and urinary tract infection. 

Development timeline for Vyvgart

Dec 17, 2021Approval FDA Approves Vyvgart (efgartigimod alfa-fcab) for the Treatment of Generalized Myasthenia Gravis
Dec  4, 2018argenx Provides Detailed Data from Phase 2 Clinical Trial of Efgartigimod in Immune Thrombocytopenia and Phase 1/2 Clinical Trial of Cusatuzumab in Acute Myeloid Leukemia
Sep  6, 2018Argenx Doses First Patient in Global Phase 3 Registration Trial of Efgartigimod

Further information

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