Efgartigimod alfa is under clinical development by Argenx and currently in the Phase II and Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Efgartigimod alfa’s likelihood of approval (LoA) and phase transition for Pemphigus Foliaceus took place on 26 Dec 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

In addition, the same event on 26 Dec 2022 increased Efgartigimod alfa’s LoA and PTSR for Pemphigus Vulgaris.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Efgartigimod alfa Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Efgartigimod alfa overview

Efgartigimod alfa-fcab (Vyvgart) is a human IgG1 antibody fragment. It is formulated as solution for infusion for intravenous route of administration. Vyvgart is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive and membranous glomerulonephritis (membranous nephropathy), lupus nephritis and Sjogren's syndrome and COVID-19 mediated postural orthostatic tachycardia syndrome.

It is also being developed in subcutaneous formulation for the treatment of myasthenia gravis, primary membranous nephropathy, pemphigus vulgaris, immune-mediated necrotizing myopathy, anti-synthetase syndrome and dermatomyositis, polymyositis, immune thrombocytopenia, CIDP using ENHANZE technology platform.

Argenx overview

Argenx is an immunology company that focuses on the development of human antibodies. The company is primarily developing products for autoimmune diseases. Its key product includes VYVGART, a neonatal Fc receptor blocker, which is used to treat generalized myasthenia gravis in adults which are anti-acetylcholine receptor (AChR) antibody positive. The company’s pipeline products include Efgartigimod, ARGX-117, Cusatuzumab, ARGX-118, ARGX-119 and ARGX-120. Argenx in partnership with Leo Pharma, AgoMab, AbbVie and Staten has been licensed to develop products such as ARGX-112, ARGX-114 and ARGX-115. The company develops antibodies using its proprietary technology platforms such as Nhance, simple antibody technology, and others. It operates offices in the Netherlands, the United States, Japan, Switzerland and Belgium. Argenx is headquartered in Breda, the Netherlands.

Quick View Efgartigimod alfa LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Efgartigimod alfa
Administration Pathway
  • Intravenous
  • Subcutaneous
Therapeutic Areas
  • Cardiovascular
  • Central Nervous System
  • Dermatology
  • Genito Urinary System And Sex Hormones
  • Hematological Disorders
  • Immunology
  • Musculoskeletal Disorders
Key Developers
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.