The US Food and Drug Administration (FDA) has approved Argenx\u2019s VYVGART Hytrulo to treat adults with chronic inflammatory demyelinating polyneuropathy (CIDP).<\/p>\n\n\n\n
Intended for use as a once-weekly subcutaneous injection over 30 to 90 seconds, VYVGART Hytrulo is the first and only neonatal Fc receptor (FcRn) blocker approved for this indication.<\/p>\n\n\n\n
In February 2024, the US regulator accepted Argenx\u2019s sBLA for VYVGART Hytrulo to treat CIDP, for priority review.<\/p>\n\n\n\n
The FDA\u2019s decision is based on the results of the ADHERE study.<\/p>\n\n\n\n
The study showed that 69% of subjects treated with VYVGART Hytrulo, regardless of previous treatment, showed clinical improvement including increased mobility, function and strength.<\/p>\n\n\n\n
The trial also met its primary endpoint with a statistically significant 61% reduction in the risk of relapse compared to placebo.<\/p>\n\n\n\n
99% of trial participants chose to continue in the open-label extension of ADHERE.<\/p>\n\n\n\n
The safety profile of VYVGART Hytrulo was consistent with previous clinical studies and its real-world use, with no new safety concerns reported.<\/p>\n\n\n\n
VYVGART Hytrulo is also approved in the US for generalized myasthenia gravis in adults who are anti-acetylcholine receptor antibody positive.<\/p>\n\n\n\n
argenx Chief Medical Officer Luc Truyen stated: \u201cargenx continues to pursue our ambition to turn science into solutions for patients with severe autoimmunity.<\/p>\n\n\n\n
\u201cPatients have been waiting and today argenx is delivering the first innovative treatment for CIDP in more than 30 years. VYVGART Hytrulo is a precision tool that has been shown to bring significant benefits to patients. The FDA approval means CIDP patients have a new transformative treatment option and further confirms the therapeutic profile of VYVGART Hytrulo and the potential of FcRn blockade in IgG-mediated autoimmune diseases.<\/p>\n\n\n\n
\u201cFDA Approves Argenx\u2019s VYVGART Hytrulo to Treat CIDP\u201d was originally created and published by Pharmaceutical Technology, a brand owned by GlobalData.<\/p>\n\n\n\n
#FDA #approves #Argenxs #VYVGART #Hytrulo #treat #CIDP The US Food and Drug Administration (FDA) has approved Argenx\u2019s VYVGART Hytrulo to treat adults with chronic inflammatory demyelinating polyneuropathy (CIDP). Intended for use as a once-weekly subcutaneous injection over 30 to 90 seconds, VYVGART Hytrulo is the first and only neonatal Fc receptor (FcRn) blocker approved for this indication. In February 2024, the US<\/p>\n","protected":false},"author":3,"featured_media":10984,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[29],"tags":[],"class_list":{"0":"post-9967","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-medication"},"_links":{"self":[{"href":"https:\/\/devserver.pw\/twistkoala.com\/wp-json\/wp\/v2\/posts\/9967","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/devserver.pw\/twistkoala.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/devserver.pw\/twistkoala.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/devserver.pw\/twistkoala.com\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/devserver.pw\/twistkoala.com\/wp-json\/wp\/v2\/comments?post=9967"}],"version-history":[{"count":1,"href":"https:\/\/devserver.pw\/twistkoala.com\/wp-json\/wp\/v2\/posts\/9967\/revisions"}],"predecessor-version":[{"id":10985,"href":"https:\/\/devserver.pw\/twistkoala.com\/wp-json\/wp\/v2\/posts\/9967\/revisions\/10985"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/devserver.pw\/twistkoala.com\/wp-json\/wp\/v2\/media\/10984"}],"wp:attachment":[{"href":"https:\/\/devserver.pw\/twistkoala.com\/wp-json\/wp\/v2\/media?parent=9967"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/devserver.pw\/twistkoala.com\/wp-json\/wp\/v2\/categories?post=9967"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/devserver.pw\/twistkoala.com\/wp-json\/wp\/v2\/tags?post=9967"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
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