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Efgartigimod alfa is under clinical development by Argenx and currently in Phase III for Dermatomyositis. According to GlobalData, Phase III drugs for Dermatomyositis have a 20% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Efgartigimod alfa’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

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 under development for the treatment of myasthenia gravis, primary membranous nephropathy, anti-neutrophil cytoplasmic antibody-associated vasculitis (ANCA Vasculitis), pemphigus vulgaris, Graves'' ophthalmopathy, antibody-mediated rejection (AMR), immune-mediated necrotizing myopathy, anti-synthetase syndrome and dermatomyositis, polymyositis, immune thrombocytopenia, primary Sjögren's syndrome, CIDP using ENHANZE technology platform. It is administered through intravenous route.

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.

For a complete picture of Efgartigimod alfa’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 3 November 2013

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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 clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.