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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.

Development timeline for Vyvgart

DateArticle
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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