{"id":20330,"date":"2024-12-30T22:19:35","date_gmt":"2024-12-30T14:19:35","guid":{"rendered":"https:\/\/flcube.com\/?p=20330"},"modified":"2024-12-30T22:19:39","modified_gmt":"2024-12-30T14:19:39","slug":"argenxs-vygart-hytrulo-approved-in-japan-for-chronic-inflammatory-demyelinating-polyneuropathy","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=20330","title":{"rendered":"argenx’s Vygart Hytrulo Approved in Japan for Chronic Inflammatory Demyelinating Polyneuropathy"},"content":{"rendered":"\n

Holland-based argenx SE (NASDAQ: ARGX<\/a>) has announced receiving another indication approval from Japan\u2019s Ministry of Health, Labour and Welfare (MHLW) for its Vygart Hytrulo (efgartigimod alfa subcutaneous injection; SC). This approval allows the drug to be used for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP), who can now self-administer the treatment at home. This follows an earlier MHLW approval for the use of Vygart Hytrulo in generalized myasthenia gravis (gMG) in January this year.<\/p>\n\n\n\n

ADHERE Study Results Support Vygart Hytrulo’s Efficacy<\/strong>
The endorsement is supported by the results from the ADHERE study, which demonstrated clinical improvement, including improvements in mobility, function, and strength, in 69% (221\/322) of patients treated with Vygart Hytrulo. The study successfully met its primary endpoint (p<0.0001), showing a 61% reduction in the risk of relapse versus placebo (HR: 0.39 95% CI: 0.25; 0.61). The safety profile of Vygart Hytrulo is consistent with previous findings, further validating its use in patients with CIDP.<\/p>\n\n\n\n

Vygart Hytrulo’s Composition and Delivery Technology<\/strong>
Vygart Hytrulo is a subcutaneous combination of efgartigimod alfa, a human IgG1 antibody fragment marketed under the trade name Vygart, and recombinant human hyaluronidase PH20 (rHuPH20), utilizing Halozyme\u2019s Enhanze drug delivery technology to facilitate the subcutaneous injection delivery of biologics.<\/p>\n\n\n\n

argenx’s Licensing Deal with Zai Lab Ltd<\/strong>
China-based biotech Zai Lab Ltd (NASDAQ: ZLAB<\/a>, HKG: 9688<\/a>) obtained the rights to Vygart Hytrulo through a licensing deal with argenx in 2021, expanding the drug’s reach into the Chinese market and further solidifying argenx’s position as a global player in the biologics space.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

Holland-based argenx SE (NASDAQ: ARGX) has announced receiving another indication approval from Japan\u2019s Ministry of…<\/p>\n","protected":false},"author":1,"featured_media":20331,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[2037,869,1131,868,15,24,413],"class_list":["post-20330","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-argenx-se","tag-hkg-9688","tag-nasdaq-argx","tag-nasdaq-zlab","tag-product-approvals","tag-rare-orphan-disease-drugs","tag-zai-lab"],"yoast_head":"\nargenx's Vygart Hytrulo Approved in Japan for Chronic Inflammatory Demyelinating Polyneuropathy - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Holland-based argenx SE (NASDAQ: ARGX) has announced receiving another indication approval from Japan\u2019s Ministry of Health, Labour and Welfare (MHLW) for its Vygart Hytrulo (efgartigimod alfa subcutaneous injection; SC). 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