(Efgartigimod alfa + hyaluronidase (human recombinant)) is under clinical development by Argenx and currently in Phase III for Graves’ Ophthalmopathy. According to GlobalData, Phase III drugs for Graves’ Ophthalmopathy have a 50% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how (Efgartigimod alfa + hyaluronidase (human recombinant))’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 + hyaluronidase (human recombinant)) overview

Efgartigimod alfa and Hyaluronidase (Vyvgart Hytrulo / Vyvgart SC) is a human IgG1 antibody fragment, acts as an endoglycosidase enzyme. It is formulated as solution and concentrated solution for subcutaneous route of administration. Vyvgart Hytrulo is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.

The drug candidate is under development for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP), Myasthenia Gravis and thyroid eye disease. It is administered through subcutaneous route.

It was also under development for the treatment of thrombocytopenia, pemphigus vulgaris (PV) and pemphigus foliaceus (PF)

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 + hyaluronidase (human recombinant))’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 10 June 2024

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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.