{"id":12723,"date":"2022-05-05T14:40:11","date_gmt":"2022-05-05T18:40:11","guid":{"rendered":"https:\/\/www.med.unc.edu\/neurology\/?p=12723"},"modified":"2023-11-17T14:36:20","modified_gmt":"2023-11-17T19:36:20","slug":"fda-approves-treatment-for-myasthenia-gravis-after-phase-iii-study-led-by-james-howard-md","status":"publish","type":"post","link":"https:\/\/www.med.unc.edu\/neurology\/fda-approves-treatment-for-myasthenia-gravis-after-phase-iii-study-led-by-james-howard-md\/","title":{"rendered":"FDA Approves Treatment for Myasthenia Gravis After Phase III Study Led by James Howard, MD"},"content":{"rendered":"<p><img loading=\"lazy\" decoding=\"async\" class=\"alignright wp-image-12664\" src=\"https:\/\/www.med.unc.edu\/neurology\/wp-content\/uploads\/sites\/716\/2022\/04\/James-F-Howard-Jr-MD-preferred-225x300.jpg\" alt=\"James F. Howard, Jr, MD\" width=\"125\" height=\"167\" srcset=\"https:\/\/www.med.unc.edu\/neurology\/wp-content\/uploads\/sites\/716\/2022\/04\/James-F-Howard-Jr-MD-preferred-225x300.jpg 225w, https:\/\/www.med.unc.edu\/neurology\/wp-content\/uploads\/sites\/716\/2022\/04\/James-F-Howard-Jr-MD-preferred-768x1024.jpg 768w, https:\/\/www.med.unc.edu\/neurology\/wp-content\/uploads\/sites\/716\/2022\/04\/James-F-Howard-Jr-MD-preferred-1152x1536.jpg 1152w, https:\/\/www.med.unc.edu\/neurology\/wp-content\/uploads\/sites\/716\/2022\/04\/James-F-Howard-Jr-MD-preferred-600x800.jpg 600w, https:\/\/www.med.unc.edu\/neurology\/wp-content\/uploads\/sites\/716\/2022\/04\/James-F-Howard-Jr-MD-preferred.jpg 1188w\" sizes=\"auto, (max-width: 125px) 100vw, 125px\" \/><\/p>\n<p>The approval by the Food and Drug Administration (FDA) was based on positive results from the CHAMPION-MG Phase III trial, in which\u00a0<i>Ultomiris<\/i>\u00a0was superior to placebo in the primary endpoint of change from baseline in the Myasthenia Gravis-Activities of Daily Living Profile (MG-ADL) total score at Week 26, a patient-reported scale that assesses patients\u2019 abilities to perform daily activities.<\/p>\n<p>This FDA action marks the first and only approval for a long-acting C5 complement inhibitor for the treatment of gMG,\u00a0a rare, debilitating, chronic, autoimmune neuromuscular disease that leads to a loss of muscle function and severe weakness. The diagnosed prevalence of gMG in the US is estimated at approximately 90,000.<sup>7<\/sup><\/p>\n<p><a href=\"https:\/\/www.med.unc.edu\/neurology\/directory\/james-f-howard-jr-md\/\">James F. Howard, Jr, MD<\/a>, professor in the UNC Department of Neurology, and lead primary investigator in the CHAMPION-MG trial said: \u201cDespite recent advances, managing gMG is complex. Earlier intervention can preserve function and quality of life. This approval offers patients, including those with milder symptoms, a long-acting C5 inhibitor with early onset and reliable efficacy.\u201d<\/p>\n<p>Read the <a href=\"https:\/\/www.astrazeneca.com\/media-centre\/press-releases\/2022\/ultomiris-approved-in-the-us-for-adults-with-generalised-myasthenia-gravis.html\">full press release from AstraZeneca<\/a>, which released news of the FDA approval.<\/p>\n<p>James F. Howard, Jr, MD<\/p>\n","protected":false},"excerpt":{"rendered":"<p>James F. Howard, Jr, MD, in the UNC Department of Neurology is the lead primary investigator in the CHAMPION-MG trial for Ultomiris (ravulizumab-cwvz) as a treatment for adults with generalised myasthenia gravis who are anti-acetylcholine receptor antibody-positive, which represents 80% of people living with the disease. <\/p>\n","protected":false},"author":58435,"featured_media":12664,"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":[48,2,134],"tags":[],"class_list":["post-12723","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","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 Treatment for Myasthenia Gravis After Phase III Study Led by James Howard, MD | 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-treatment-for-myasthenia-gravis-after-phase-iii-study-led-by-james-howard-md\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA Approves Treatment for Myasthenia Gravis After Phase III Study Led by James Howard, MD | Department of Neurology\" \/>\n<meta property=\"og:description\" content=\"James F. Howard, Jr, MD, in the UNC Department of Neurology is the lead primary investigator in the CHAMPION-MG trial for Ultomiris (ravulizumab-cwvz) as a treatment for adults with generalised myasthenia gravis who are anti-acetylcholine receptor antibody-positive, which represents 80% of people living with the disease.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.med.unc.edu\/neurology\/fda-approves-treatment-for-myasthenia-gravis-after-phase-iii-study-led-by-james-howard-md\/\" \/>\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=\"2022-05-05T18:40:11+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2023-11-17T19:36:20+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.med.unc.edu\/neurology\/wp-content\/uploads\/sites\/716\/2022\/04\/James-F-Howard-Jr-MD-preferred.jpg\" 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