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Efgartigimod alfa - argenx

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Drug Profile

Efgartigimod alfa - argenx

Alternative Names: ARGX-113; EFG PH20 SC; Efgartigimod - argenx; Efgartigimod alfa-fcab - argenx; efgartigimod PH20; efgartigimod PH20 SC; PH20 SC; VYVDURA; VYVGART; Vyvgart; VYVGART HYTRULO

Latest Information Update: 02 Sep 2025

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At a glance

  • Originator arGEN-X
  • Developer argenx; Medison; ZAI Lab
  • Class Anti-inflammatories; Antiarrhythmics; Immunoglobulin Fc fragments; Monoclonal antibodies; Skin disorder therapies; Urologics
  • Mechanism of Action Neonatal Fc receptor antagonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Idiopathic thrombocytopenic purpura; Chronic inflammatory demyelinating polyradiculoneuropathy; Myasthenia gravis
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Chronic inflammatory demyelinating polyradiculoneuropathy; Myasthenia gravis
  • Registered Idiopathic thrombocytopenic purpura
  • Phase III Bullous pemphigoid; Graves ophthalmopathy; Myositis; Pemphigus; Sjogren's syndrome
  • Phase II Lupus nephritis; Renal transplant rejection
  • Preclinical Immune-mediated necrotising myopathy
  • Discontinued Anti-neutrophil cytoplasmic antibody-associated vasculitis; Membranous glomerulonephritis; Postural orthostatic tachycardia syndrome

Most Recent Events

  • 25 Aug 2025 argenx plans to submit supplemental BLA to the US FDA for seeking expansion of the VYVGART label for Myasthenia gravis by end of 2025
  • 25 Aug 2025 Efficacy and adverse events data from a phase III ADAPT SERON trial in Myasthenia gravis released by argenx
  • 07 Aug 2025 ZAI Labs announces intention to submit NDA to NMPA for prefilled syringe in generalized myasthenia gravis and chronic inflammatory demyelinating polyneuropathy in the second half of 2025

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