Efgartigimod alfa is under clinical development by Argenx and currently in Phase III for Idiopathic Inflammatory Myopathy (IIM). According to GlobalData, Phase III drugs for Idiopathic Inflammatory Myopathy (IIM) 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 concentrated solution for infusion for intravenous and solution for subcutaneous 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, idiopathic inflammatory myopathy (IIM), anti-neutrophil cytoplasmic antibody-associated vasculitis (ANCA Vasculitis), Graves'' ophthalmopathy, antibody-mediated rejection (AMR), immune-mediated necrotizing myopathy, anti-synthetase syndrome, dermatomyositis, polymyositis, immune thrombocytopenia, primary Sjögren's syndrome, CIDP using ENHANZE technology platform. It is administered through intravenous route.

It was also under development for rheumatoid arthritis and pemphigus.

Argenx overview

Argenx is an immunology company that developed human antibody products for autoimmune diseases. The company’s product includes VYVGART, a neonatal Fc receptor blocker, which is used to treat generalized myasthenia gravis in adults. The company’s pipeline products include Efgartigimod, ARGX-117, Cusatuzumab, ARGX-118 and ARGX-119. 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. Argenxis headquartered in Amsterdam, Noord-Holland, 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 7 February 2024

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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.