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Efgartigimod alfa - argenx

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 HYTRULO

Latest Information Update: 18 Mar 2024

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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 Myasthenia gravis
  • Preregistration Chronic inflammatory demyelinating polyradiculoneuropathy; Idiopathic thrombocytopenic purpura
  • Phase III Bullous pemphigoid; Myositis; Pemphigus
  • Phase II Lupus nephritis; Membranous glomerulonephritis; Sjogren's syndrome; Tachycardia
  • Preclinical Immune-mediated necrotising myopathy

Most Recent Events

  • 18 Mar 2024 argenx plans a phase III trial in Graves ophthalmopathy (SC) (NCT06307626)
  • 07 Mar 2024 Argenx plans phase-III trial for Myasthenia gravis (Treatment-experienced, In children, In adolescents, In adults, In the elderly) in April 2024 (IV, infusion) (NCT06298552)
  • 29 Feb 2024 argenx expects regulatory approval decision on efgartigimod for Myasthenia gravis in Switzerland, Australia, Saudi Arabia and South Korea by end of 2024
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