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
Further information
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