Efgartigimod alfa is under clinical development by Argenx and currently in Phase III for Idiopathic Thrombocytopenic Purpura (Immune Thrombocytopenic Purpura). According to GlobalData, Phase III drugs for Idiopathic Thrombocytopenic Purpura (Immune Thrombocytopenic Purpura) have a 73% 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 (thyroid eye disease, TED), antibody-mediated rejection (AMR), systemic sclerosis 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 develops 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-119 targets congenital myasthenic syndrome and amyotrophic lateral sclerosis; ARGX-109, ARGX-121, ARGX-213 and ARGX-220. 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.
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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.
