{"id":33234,"date":"2025-09-02T17:15:55","date_gmt":"2025-09-02T11:45:55","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=33234"},"modified":"2025-09-02T17:16:28","modified_gmt":"2025-09-02T11:46:28","slug":"pharma-news-for-eisai-travere-sanofi","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-eisai-travere-sanofi","title":{"rendered":"FDA Approves Eisai &amp; Biogen\u2019s LEQEMBI IQLIK for Maintenance Treatment of Early Alzheimer\u2019s; Travere Therapeutics Gains FDA Nod for FILSPARI REMS Update in IgA Nephropathy; Vanda Pharmaceuticals\u2019 VGT-1849B Granted FDA Orphan Drug Status for Polycythemia Vera; Teva Launches First FDA-Approved Generic SAXENDA for Weight Loss; Sanofi\u2019s WAYRILZ Gets FDA Approval as First BTK Inhibitor for Immune Thrombocytopenia"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_76 counter-hierarchy ez-toc-counter ez-toc-white ez-toc-container-direction\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<label for=\"ez-toc-cssicon-toggle-item-69e6533bef445\" class=\"ez-toc-cssicon-toggle-label\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/label><input type=\"checkbox\"  id=\"ez-toc-cssicon-toggle-item-69e6533bef445\"  aria-label=\"Toggle\" \/><nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-eisai-travere-sanofi\/#FDA_Approves_Eisai_Biogens_LEQEMBI_IQLIK_for_Maintenance_Treatment_of_Early_Alzheimers\" >FDA Approves Eisai &amp; Biogen\u2019s LEQEMBI IQLIK for Maintenance Treatment of Early Alzheimer\u2019s<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-eisai-travere-sanofi\/#Travere_Therapeutics_Gains_FDA_Nod_for_FILSPARI_REMS_Update_in_IgA_Nephropathy\" >Travere Therapeutics Gains FDA Nod for FILSPARI REMS Update in IgA Nephropathy<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-eisai-travere-sanofi\/#Vanda_Pharmaceuticals_VGT-1849B_Granted_FDA_Orphan_Drug_Status_for_Polycythemia_Vera\" >Vanda Pharmaceuticals\u2019 VGT-1849B Granted FDA Orphan Drug Status for Polycythemia Vera<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-eisai-travere-sanofi\/#Teva_Launches_First_FDA-Approved_Generic_SAXENDA_for_Weight_Loss\" >Teva Launches First FDA-Approved Generic SAXENDA for Weight Loss<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-eisai-travere-sanofi\/#Sanofis_WAYRILZ_Gets_FDA_Approval_as_First_BTK_Inhibitor_for_Immune_Thrombocytopenia\" >Sanofi\u2019s WAYRILZ Gets FDA Approval as First BTK Inhibitor for Immune Thrombocytopenia<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\" id=\"h-fda-approves-eisai-amp-biogen-s-leqembi-iqlik-for-maintenance-treatment-of-early-alzheimer-s\"><span class=\"ez-toc-section\" id=\"FDA_Approves_Eisai_Biogens_LEQEMBI_IQLIK_for_Maintenance_Treatment_of_Early_Alzheimers\"><\/span>FDA Approves Eisai &amp; Biogen\u2019s LEQEMBI IQLIK for Maintenance Treatment of Early Alzheimer\u2019s<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Eisai Co., Ltd. <\/strong>and <strong>Biogen Inc.<\/strong> announced that the FDA has approved the <strong>Biologics License Application (BLA) <\/strong>for <strong>LEQEMBI IQLIK<\/strong> (lecanemab-irmb), a once-weekly 360 mg subcutaneous autoinjector designed for maintenance dosing in <a href=\"https:\/\/www.delveinsight.com\/report-store\/alzheimers-disease-ad-market\"><strong>patients with<\/strong> <strong>early Alzheimer\u2019s disease<\/strong><\/a>. The device, which administers treatment in approximately 15 seconds, offers patients an alternative to intravenous (IV) infusions.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cWe believe LEQEMBI IQLIK represents a major step forward in patient-centered Alzheimer\u2019s care,\u201d said Haruo Naito, CEO of Eisai. \u201cBy providing a simple at-home option, we are expanding access and improving convenience for patients and their care partners.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>The approval is based on sub-studies of the phase III Clarity AD open-label extension, which showed that weekly subcutaneous administration maintained clinical and biomarker benefits comparable to IV dosing. In more than 600 patients studied, the safety profile of the autoinjector was consistent with IV therapy, though systemic reactions were far less frequent (&lt;1% compared with ~26% for IV). Mild local reactions, such as redness or itching at the injection site, were observed in about 11% of patients and did not interfere with continued treatment.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>Christopher A. Viehbacher, CEO of Biogen, added: \u201cThe approval of this new formulation underscores our commitment to providing flexible options that can help patients maintain their independence for longer. LEQEMBI IQLIK simplifies ongoing therapy while supporting broader healthcare system efficiency.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>Alzheimer\u2019s disease is a progressive condition driven by amyloid beta and tau pathology. LEQEMBI is the first and only approved therapy that targets both amyloid plaques and protofibrils, which are considered among the most toxic forms of amyloid beta. Maintenance treatment, administered through weekly subcutaneous injections or monthly IV infusions, ensures the continued slowing of disease progression and helps patients preserve their quality of life. Eisai and Biogen plan to launch LEQEMBI IQLIK in the U.S. on October 6, 2025.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-travere-therapeutics-gains-fda-nod-for-filspari-rems-update-in-iga-nephropathy\"><span class=\"ez-toc-section\" id=\"Travere_Therapeutics_Gains_FDA_Nod_for_FILSPARI_REMS_Update_in_IgA_Nephropathy\"><\/span>Travere Therapeutics Gains FDA Nod for FILSPARI REMS Update in IgA Nephropathy<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Travere Therapeutics, Inc.<\/strong> announced that the FDA has approved an update to the Risk Evaluation and Mitigation Strategy (REMS) for<strong> FILSPARI (sparsentan),<\/strong> the first and only Dual Endothelin Angiotensin Receptor Antagonist for <a href=\"https:\/\/www.delveinsight.com\/report-store\/iga-nephropathy-igan-market\"><strong>IgA nephropathy (IgAN)<\/strong><\/a>. The changes reduce liver function monitoring to every three months from treatment initiation and remove embryo-fetal toxicity monitoring from the REMS requirements.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cFILSPARI is becoming a foundational treatment for people living with IgA nephropathy, giving patients and their families hope for slowing the progression of their disease,\u201d said Jula Inrig, M.D., chief medical officer of Travere Therapeutics. \u201cToday\u2019s approval of streamlined monitoring requirements reflects the strong safety profile of FILSPARI established to date across clinical and real-world use, simplifying access for patients.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>The FDA decision was supported by post-marketing surveillance data and results from the Phase III PROTECT study in IgAN, as well as findings from the Phase III DUPLEX and Phase II DUET studies. The agency also determined that embryo-fetal toxicity monitoring was no longer required, based on two decades of human pregnancy data with ERA medicines.<\/p>\n\n\n\n<p>Looking ahead, a supplemental New Drug Application (sNDA) for FILSPARI in focal segmental glomerulosclerosis (FSGS) remains under FDA review, with a Prescription Drug User Fee Act (PDUFA) target action date of January 13, 2026. If approved, FILSPARI would become the first medicine available for FSGS, further expanding its impact across kidney disease care.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-vanda-pharmaceuticals-vgt-1849b-granted-fda-orphan-drug-status-for-polycythemia-vera\"><span class=\"ez-toc-section\" id=\"Vanda_Pharmaceuticals_VGT-1849B_Granted_FDA_Orphan_Drug_Status_for_Polycythemia_Vera\"><\/span>Vanda Pharmaceuticals\u2019 VGT-1849B Granted FDA Orphan Drug Status for Polycythemia Vera<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Vanda Pharmaceuticals Inc.<\/strong> announced that the FDA has granted <strong>Orphan Drug Designation <\/strong>to <strong>VGT-1849B,<\/strong> a selective peptide nucleic acid-based JAK2 inhibitor for the <a href=\"https:\/\/www.delveinsight.com\/report-store\/polycythemia-vera-market\"><strong>treatment of polycythemia vera<\/strong><\/a>, a rare chronic myeloproliferative disorder affecting an estimated 44 to 57 per 100,000 people in the U.S.<\/p>\n\n\n\n<p><em>\u201cThis designation underscores the potential of VGT-1849B to address a significant unmet need in polycythemia vera by offering a highly selective approach to JAK2 inhibition,\u201d said Mihael H. Polymeropoulos, M.D., president and CEO of Vanda Pharmaceuticals. \u201cWe believe this novel therapy could improve safety outcomes for patients who currently have limited options.\u201d<\/em><\/p>\n\n\n\n<p>VGT-1849B is designed using OliPass Peptide Nucleic Acid (OPNA) technology, which enhances cell permeability and RNA binding. By selectively targeting JAK2 mRNA, the therapy suppresses aberrant hematopoiesis while minimizing off-target kinase effects\u2014a challenge seen with currently available JAK inhibitors such as Jakafi\u00ae, Inrebic\u00ae, Ojjaara\u00ae, and Vonjo\u00ae.<\/p>\n\n\n\n<p>If approved, VGT-1849B could emerge as the first highly selective JAK2 inhibitor, aiming to reduce red blood cell overproduction, alleviate disease burden, and improve quality of life for PV patients through targeted efficacy and a favorable safety profile.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-teva-launches-first-fda-approved-generic-saxenda-for-weight-loss\"><span class=\"ez-toc-section\" id=\"Teva_Launches_First_FDA-Approved_Generic_SAXENDA_for_Weight_Loss\"><\/span>Teva Launches First FDA-Approved Generic SAXENDA for Weight Loss<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Teva Pharmaceuticals, Inc.<\/strong>, the U.S. affiliate of<strong> Teva Pharmaceutical Industries Ltd.<\/strong>, announced that the FDA has approved and the company has launched the first generic version of<strong> SAXENDA (liraglutide injection)<\/strong>, marking a major milestone in the weight loss treatment landscape.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cWith this approval, and by launching a generic for SAXENDA, we will provide patients in the U.S. the first ever generic GLP-1 product specifically indicated for weight loss,\u201d said Ernie Richardsen, SVP, Head of U.S. Commercial Generics at Teva. \u201cThis is the fifth first-to-market entry of a Teva generic this year and is an important addition to Teva&#8217;s diverse complex generics portfolio, demonstrating once again our proven ability to sustain a world-class Generics Powerhouse.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>Generic SAXENDA enters a fast-growing category of GLP-1 therapies, offering a more accessible option for patients seeking weight management solutions. SAXENDA recorded annual U.S. sales of $165 million as of June 2025, highlighting the strong demand for effective <a href=\"https:\/\/www.delveinsight.com\/report-store\/weight-loss-weight-management-obesity-market\">obesity treatments<\/a>.<\/p>\n\n\n\n<p>Liraglutide injection is indicated for adults with obesity or overweight who also have weight-related medical conditions, as well as adolescents aged 12\u201317 years with obesity weighing over 60 kg. The approval reinforces Teva\u2019s Pivot to Growth Strategy and its continued commitment to expanding its complex generics portfolio.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-sanofi-s-wayrilz-gets-fda-approval-as-first-btk-inhibitor-for-immune-thrombocytopenia\"><span class=\"ez-toc-section\" id=\"Sanofis_WAYRILZ_Gets_FDA_Approval_as_First_BTK_Inhibitor_for_Immune_Thrombocytopenia\"><\/span>Sanofi\u2019s WAYRILZ Gets FDA Approval as First BTK Inhibitor for Immune Thrombocytopenia<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The FDA has approved <strong>Sanofi\u2019s WAYRILZ (rilzabrutinib)<\/strong> for adults with<strong> <\/strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/immune-thrombocytopenia-itp-market\"><strong>persistent or chronic immune thrombocytopenia (ITP)<\/strong><\/a> who have not responded adequately to a prior therapy. The approval is based on data from the pivotal LUNA III trial, which demonstrated rapid and durable platelet responses, improvements in ITP symptoms, and meaningful gains in quality of life.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cThe burden of immune thrombocytopenia can be both physical and emotional with significant overlooked symptoms that can impact various aspects of daily living,\u201d said Caroline Kruse, President and CEO of the Platelet Disorder Support Association. \u201cWe are pleased to have a new treatment option that can help ease the ongoing strain of managing the disease for patients and their families.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>WAYRILZ is the first oral, reversible Bruton\u2019s tyrosine kinase (BTK) inhibitor approved for ITP. By acting through multi-immune modulation, it targets key pathways that drive the disease, representing a novel approach compared to existing therapies. In the LUNA III study, 23% of patients treated with WAYRILZ achieved a durable platelet response at week 25 compared to none in the placebo arm, with faster onset and longer duration of platelet response. Patients also reported notable improvements in quality-of-life measures.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cWith its differentiated mechanism of action, WAYRILZ has the potential to become a treatment of choice for immune thrombocytopenia patients who have not responded to a prior therapy,\u201d said Brian Foard, Executive Vice President, Head of Specialty Care at Sanofi. \u201cThis approval underscores Sanofi\u2019s expertise and ambitions at the junction of rare and immunological disease.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>WAYRILZ was also recently approved in the UAE and is under regulatory review in the EU and China. It has received FDA Fast Track and Orphan Drug Designations for ITP, along with orphan designations in Japan and the EU. Beyond ITP, WAYRILZ is being investigated for other rare immune-mediated conditions, including warm autoimmune hemolytic anemia, IgG4-related disease, and sickle cell disease.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>FDA Approves Eisai &amp; Biogen\u2019s LEQEMBI IQLIK for Maintenance Treatment of Early Alzheimer\u2019s Eisai Co., Ltd. and Biogen Inc. announced that the FDA has approved the Biologics License Application (BLA) for LEQEMBI IQLIK (lecanemab-irmb), a once-weekly 360 mg subcutaneous autoinjector designed for maintenance dosing in patients with early Alzheimer\u2019s disease. The device, which administers treatment [&hellip;]<\/p>\n","protected":false},"author":20,"featured_media":33235,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_editorskit_title_hidden":false,"_editorskit_reading_time":0,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":""},"categories":[32],"tags":[1407,7145,6642,6641,72,204,704,18841,18839,18838,12945,12942,12944,349,420,1173,20479,18881,20478,20477,19430,639,19101,20436,20440],"industry":[17225],"therapeutic_areas":[17240,17233,17227,17245],"class_list":["post-33234","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-alzheimer","tag-alzheimers-disease-market","tag-alzheimers-disease-pipeline","tag-alzheimers-disease-therapies","tag-alzheimers-disease","tag-delveinsight","tag-fda","tag-iga-nephropathy","tag-iga-nephropathy-drug-pipeline","tag-iga-nephropathy-market","tag-immune-thrombocytopenia","tag-immune-thrombocytopenia-market","tag-immune-thrombocytopenia-treatment-market","tag-latest-pharma-news","tag-news","tag-obesity","tag-obesity-drugs","tag-obesity-market","tag-obesity-pipeline","tag-obesity-therapies","tag-obesity-treatment","tag-pharma-news","tag-polycythemia-vera","tag-polycythemia-vera-treatment","tag-polycythemia-vera-treatment-market","industry-pharmaceutical","therapeutic_areas-endocrinology-and-metabolic-disorders","therapeutic_areas-hematological-disorders","therapeutic_areas-immunological-and-autoimmune-disorders","therapeutic_areas-neurology"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.8 (Yoast SEO v25.8) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Pharma News | Eisai, Travere, Sanofi<\/title>\n<meta name=\"description\" content=\"Eisai &amp; Biogen\u2019s LEQEMBI IQLIK; Travere\u2019s FILSPARI; Vanda\u2019s VGT-1849B; Teva\u2019s Generic SAXENDA; Sanofi\u2019s WAYRILZ\" \/>\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.delveinsight.com\/blog\/pharma-news-for-eisai-travere-sanofi\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pharma News | Eisai, Travere, Sanofi\" \/>\n<meta property=\"og:description\" content=\"Eisai &amp; Biogen\u2019s LEQEMBI IQLIK; Travere\u2019s FILSPARI; Vanda\u2019s VGT-1849B; Teva\u2019s Generic SAXENDA; Sanofi\u2019s WAYRILZ\" \/>\n<meta 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