Efgartigimod: First Approval

Efgartigimod (efgartigimod alfa-fcab, Vyvgart(™)) is a first-in-class neonatal Fc receptor antagonist being developed by argenx for the treatment of autoimmune diseases including myasthenia gravis. In December 2021, intravenous efgartigimod received its first approval in the USA for the treatment of...

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Autor principal: Heo, Young-A
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8855644/
https://www.ncbi.nlm.nih.gov/pubmed/35179720
http://dx.doi.org/10.1007/s40265-022-01678-3
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author Heo, Young-A
author_facet Heo, Young-A
author_sort Heo, Young-A
collection PubMed
description Efgartigimod (efgartigimod alfa-fcab, Vyvgart(™)) is a first-in-class neonatal Fc receptor antagonist being developed by argenx for the treatment of autoimmune diseases including myasthenia gravis. In December 2021, intravenous efgartigimod received its first approval in the USA for the treatment of generalized myasthenia gravis in adults who are anti-acetylcholine receptor (AChR) antibody positive. Intravenous efgartigimod has also been evaluated for generalized myasthenia gravis in various other countries, with the agent subsequently approved in Japan in January 2022 for generalized myasthenia gravis patients regardless of antibody status and in preregistration stage in the EU. Several clinical studies of intravenous and subcutaneous formulation of efgartigimod are also being investigated for other autoimmune diseases including bullous pemphigoid, chronic inflammatory demyelinating polyradiculoneuropathy, immune thrombocytopenia, autoimmune myositis and pemphigus. This article summarizes the milestones in the development of efgartigimod leading to this first approval for generalized myasthenia gravis. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40265-022-01678-3.
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spelling pubmed-88556442022-02-18 Efgartigimod: First Approval Heo, Young-A Drugs AdisInsight Report Efgartigimod (efgartigimod alfa-fcab, Vyvgart(™)) is a first-in-class neonatal Fc receptor antagonist being developed by argenx for the treatment of autoimmune diseases including myasthenia gravis. In December 2021, intravenous efgartigimod received its first approval in the USA for the treatment of generalized myasthenia gravis in adults who are anti-acetylcholine receptor (AChR) antibody positive. Intravenous efgartigimod has also been evaluated for generalized myasthenia gravis in various other countries, with the agent subsequently approved in Japan in January 2022 for generalized myasthenia gravis patients regardless of antibody status and in preregistration stage in the EU. Several clinical studies of intravenous and subcutaneous formulation of efgartigimod are also being investigated for other autoimmune diseases including bullous pemphigoid, chronic inflammatory demyelinating polyradiculoneuropathy, immune thrombocytopenia, autoimmune myositis and pemphigus. This article summarizes the milestones in the development of efgartigimod leading to this first approval for generalized myasthenia gravis. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40265-022-01678-3. Springer International Publishing 2022-02-18 2022 /pmc/articles/PMC8855644/ /pubmed/35179720 http://dx.doi.org/10.1007/s40265-022-01678-3 Text en © Springer Nature 2022, corrected publication 2022 https://creativecommons.org/licenses/by-nc/4.0/Open Access This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle AdisInsight Report
Heo, Young-A
Efgartigimod: First Approval
title Efgartigimod: First Approval
title_full Efgartigimod: First Approval
title_fullStr Efgartigimod: First Approval
title_full_unstemmed Efgartigimod: First Approval
title_short Efgartigimod: First Approval
title_sort efgartigimod: first approval
topic AdisInsight Report
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8855644/
https://www.ncbi.nlm.nih.gov/pubmed/35179720
http://dx.doi.org/10.1007/s40265-022-01678-3
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