{"id":12341,"date":"2022-01-03T17:05:22","date_gmt":"2022-01-03T22:05:22","guid":{"rendered":"https:\/\/www.med.unc.edu\/neurology\/?p=12341"},"modified":"2023-11-17T14:37:52","modified_gmt":"2023-11-17T19:37:52","slug":"fda-approves-new-drug-to-treat-generalized-myasthenia-gravis","status":"publish","type":"post","link":"https:\/\/www.med.unc.edu\/neurology\/fda-approves-new-drug-to-treat-generalized-myasthenia-gravis\/","title":{"rendered":"FDA approves new drug to treat generalized myasthenia gravis"},"content":{"rendered":"<p>Argenx, a Belgian drug maker, recently announced that the U.S. Food and Drug Administration (FDA) has approved VYVGART\u2122 (efgartigimod alfa-facab) for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. These patients represent approximately 85% of the total gMG population. With this regulatory milestone, VYVGART is the first-and-only FDA-approved neonatal Fc receptor blocker.<\/p>\n<p>Generalized myasthenia gravis is a rare and chronic autoimmune disease where communication between nerves and muscles is disrupted, causing debilitating muscle weakness. Efgartigimod is an antibody fragment that binds to the neonatal Fc receptor resulting in a reduction of disease-causing immunoglobulin G antibodies.<\/p>\n<figure id=\"attachment_5073\" class=\"thumbnail wp-caption alignright\"><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-5073\" src=\"https:\/\/news.unchealthcare.org\/wp-content\/uploads\/sites\/1159\/2020\/06\/fda-approves-eculizumab-for-myasthenia-gravis-image2.png\" alt=\"James F. Howard Jr., MD\" width=\"201\" height=\"152\" \/><figcaption class=\"caption wp-caption-text\">James F. Howard Jr., MD<\/figcaption><\/figure>\n<p>\u201cPeople living with gMG have been in need of new treatment options that are targeted to the underlying pathogenesis of the disease and supported by clinical data,\u201d said James F. Howard Jr., MD, Professor of Neurology and Principal Investigator for the ADAPT trial. \u201cToday\u2019s approval represents an important new advance for gMG patients and families affected by this debilitating disease. This therapy has the potential to reduce the disease burden of gMG and transform the way we treat this disease.\u201d<\/p>\n<p>\u201cThe gMG community has long-awaited the FDA approval of VYVGART, especially for those patients who struggle with basic personal tasks such as speaking, chewing and swallowing food, brushing teeth and hair, and in some severe cases, breathing,\u201d commented Samantha Masterson, President and Chief Executive Officer of the Myasthenia Gravis Foundation of America. \u201cWe thank Argenx for its continued commitment to the gMG patient community, which led them to deliver this much-needed new treatment option with the potential to change the lives of many gMG patients.\u201d<\/p>\n<p>The approval of VYVGART is based on results from the global Phase 3 ADAPT trial, which were published in the July 2021 issue of <a href=\"https:\/\/www.thelancet.com\/journals\/laneur\/article\/PIIS1474-4422(21)00159-9\/fulltext\"><em>The Lancet Neurology<\/em><\/a>. The ADAPT trial met its primary endpoint, demonstrating that significantly more anti-AChR antibody positive gMG patients were responders on the MG-ADL scale following treatment with VYVGART compared with placebo (68% vs. 30%; p&lt;0.0001). Responders were defined as having at least a two-point reduction on the MG-ADL scale sustained for four or more consecutive weeks during the first treatment cycle.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>James F. Howard Jr., MD, professor in the UNC Department of Neurology, was principal investigator of the phase 3 trial for the experimental drug efgartigimod, developed by Belgian pharmaceutical company Argenx. <\/p>\n","protected":false},"author":58435,"featured_media":8494,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"layout":"","cellInformation":"","apiCallInformation":"","footnotes":"","_links_to":"","_links_to_target":""},"categories":[103,48,2,134],"tags":[],"class_list":["post-12341","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-clinical-trial-news","category-faculty","category-news","category-research","odd"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>FDA approves new drug to treat generalized myasthenia gravis | Department of Neurology<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.med.unc.edu\/neurology\/fda-approves-new-drug-to-treat-generalized-myasthenia-gravis\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA approves new drug to treat generalized myasthenia gravis | Department of Neurology\" \/>\n<meta property=\"og:description\" content=\"James F. Howard Jr., MD, professor in the UNC Department of Neurology, was principal investigator of the phase 3 trial for the experimental drug efgartigimod, developed by Belgian pharmaceutical company Argenx.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.med.unc.edu\/neurology\/fda-approves-new-drug-to-treat-generalized-myasthenia-gravis\/\" \/>\n<meta property=\"og:site_name\" content=\"Department of Neurology\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/UNCNeurology\/\" \/>\n<meta property=\"article:published_time\" content=\"2022-01-03T22:05:22+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2023-11-17T19:37:52+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.med.unc.edu\/neurology\/wp-content\/uploads\/sites\/716\/2020\/05\/DSC_5379-scaled.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"2048\" \/>\n\t<meta property=\"og:image:height\" content=\"2560\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Peggy Felix\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@UNCneurology\" \/>\n<meta name=\"twitter:site\" content=\"@UNCneurology\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Peggy Felix\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/www.med.unc.edu\/neurology\/fda-approves-new-drug-to-treat-generalized-myasthenia-gravis\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.med.unc.edu\/neurology\/fda-approves-new-drug-to-treat-generalized-myasthenia-gravis\/\"},\"author\":{\"name\":\"Peggy Felix\",\"@id\":\"https:\/\/www.med.unc.edu\/neurology\/#\/schema\/person\/14c90ff7a3e23f1201695fd9f347c9fd\"},\"headline\":\"FDA approves new drug to treat generalized myasthenia gravis\",\"datePublished\":\"2022-01-03T22:05:22+00:00\",\"dateModified\":\"2023-11-17T19:37:52+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.med.unc.edu\/neurology\/fda-approves-new-drug-to-treat-generalized-myasthenia-gravis\/\"},\"wordCount\":367,\"publisher\":{\"@id\":\"https:\/\/www.med.unc.edu\/neurology\/#organization\"},\"image\":{\"@id\":\"https:\/\/www.med.unc.edu\/neurology\/fda-approves-new-drug-to-treat-generalized-myasthenia-gravis\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/www.med.unc.edu\/neurology\/wp-content\/uploads\/sites\/716\/2020\/05\/DSC_5379-scaled.jpg\",\"articleSection\":[\"Clinical Trial News\",\"Faculty\",\"News\",\"Research\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.med.unc.edu\/neurology\/fda-approves-new-drug-to-treat-generalized-myasthenia-gravis\/\",\"url\":\"https:\/\/www.med.unc.edu\/neurology\/fda-approves-new-drug-to-treat-generalized-myasthenia-gravis\/\",\"name\":\"FDA approves new drug to treat generalized myasthenia gravis | Department of Neurology\",\"isPartOf\":{\"@id\":\"https:\/\/www.med.unc.edu\/neurology\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/www.med.unc.edu\/neurology\/fda-approves-new-drug-to-treat-generalized-myasthenia-gravis\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/www.med.unc.edu\/neurology\/fda-approves-new-drug-to-treat-generalized-myasthenia-gravis\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/www.med.unc.edu\/neurology\/wp-content\/uploads\/sites\/716\/2020\/05\/DSC_5379-scaled.jpg\",\"datePublished\":\"2022-01-03T22:05:22+00:00\",\"dateModified\":\"2023-11-17T19:37:52+00:00\",\"breadcrumb\":{\"@id\":\"https:\/\/www.med.unc.edu\/neurology\/fda-approves-new-drug-to-treat-generalized-myasthenia-gravis\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.med.unc.edu\/neurology\/fda-approves-new-drug-to-treat-generalized-myasthenia-gravis\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/www.med.unc.edu\/neurology\/fda-approves-new-drug-to-treat-generalized-myasthenia-gravis\/#primaryimage\",\"url\":\"https:\/\/www.med.unc.edu\/neurology\/wp-content\/uploads\/sites\/716\/2020\/05\/DSC_5379-scaled.jpg\",\"contentUrl\":\"https:\/\/www.med.unc.edu\/neurology\/wp-content\/uploads\/sites\/716\/2020\/05\/DSC_5379-scaled.jpg\",\"width\":2048,\"height\":2560,\"caption\":\"James F. 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