{"id":31438,"date":"2025-04-08T14:22:03","date_gmt":"2025-04-08T08:52:03","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=31438"},"modified":"2025-05-01T16:22:52","modified_gmt":"2025-05-01T10:52:52","slug":"pharma-news-for-amgen-novartis-biogen","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-amgen-novartis-biogen","title":{"rendered":"Amgen\u2019s UPLIZNA Wins First FDA Nod for IgG4-Related Disease; Aldeyra Gets FDA CRL for Reproxalap in Dry Eye; Novartis\u2019 Vanrafia Snags Accelerated FDA OK for IgAN Proteinuria; Biogen\u2019s BIIB080 Earns Fast Track for Alzheimer\u2019s; Epicrispr\u2019s EPI-321 Cleared by FDA for FSHD"},"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-6a10989f769f3\" 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-6a10989f769f3\"  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-amgen-novartis-biogen\/#Amgens_UPLIZNA_Becomes_First_FDA-Approved_Treatment_for_IgG4-Related_Disease\" >Amgen\u2019s UPLIZNA Becomes First FDA-Approved Treatment for IgG4-Related Disease<\/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-amgen-novartis-biogen\/#Aldeyra_Receives_FDA_Complete_Response_Letter_for_Reproxalap_in_Dry_Eye_Disease\" >Aldeyra Receives FDA Complete Response Letter for Reproxalap in Dry Eye Disease<\/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-amgen-novartis-biogen\/#FDA_Grants_Accelerated_Approval_to_Novartis_Vanrafia_for_Proteinuria_in_IgA_Nephropathy\" >FDA Grants Accelerated Approval to Novartis&#8217; Vanrafia for Proteinuria in IgA Nephropathy<\/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-amgen-novartis-biogen\/#Biogens_Tau-Targeting_Therapy_BIIB080_Gets_FDA_Fast_Track_for_Alzheimers_Treatment\" >Biogen&#8217;s Tau-Targeting Therapy BIIB080 Gets FDA Fast Track for Alzheimer\u2019s Treatment<\/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-amgen-novartis-biogen\/#Epicrispr_Receives_FDA_IND_Clearance_for_EPI-321_in_FSHD_Treatment\" >Epicrispr Receives FDA IND Clearance for EPI-321 in FSHD Treatment<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\" id=\"h-amgen-s-uplizna-becomes-first-fda-approved-treatment-for-igg4-related-disease\"><span class=\"ez-toc-section\" id=\"Amgens_UPLIZNA_Becomes_First_FDA-Approved_Treatment_for_IgG4-Related_Disease\"><\/span>Amgen\u2019s UPLIZNA Becomes First FDA-Approved Treatment for IgG4-Related Disease<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Amgen<\/strong> announced that the FDA has approved <strong>UPLIZNA<\/strong> (inebilizumab-cdon) as the first and only treatment for adults with <a href=\"https:\/\/www.delveinsight.com\/report-store\/igg4-related-disease-market\"><strong>Immunoglobulin G4-related disease (IgG4-RD)<\/strong><\/a>, a rare and chronic immune-mediated inflammatory condition that can affect multiple organ systems. The approval marks a significant milestone for patients living with IgG4-RD, which often mimics other diseases and may result in fibrosis or permanent organ damage if left untreated. UPLIZNA had previously received Breakthrough Therapy Designation for this indication, highlighting the urgent need for effective therapies.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cThe FDA approval of UPLIZNA marks a significant turning point for IgG4-RD patients and physicians,\u201d said Dr. Jay Bradner, EVP of Research and Development at Amgen. \u201cThis therapy targets a key driver of the disease and reduces flare risk without long-term steroid dependence. We are proud to deliver a treatment that not only improves patient care but also reflects our broader efforts in immune-mediated diseases.\u201d Dr. John Stone, principal investigator of the pivotal MITIGATE trial, added, \u201cTargeting CD19+ B cells with UPLIZNA has proven to be a highly effective approach. This is a major step forward for the clinical community and patients alike.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>The FDA\u2019s decision is backed by data from the <strong>MITIGATE trial<\/strong>, the first randomized, double-blind, placebo-controlled study conducted in IgG4-RD. The trial showed that UPLIZNA significantly reduced disease flares while maintaining a consistent safety profile. The approval adds a second indication to UPLIZNA, which was first cleared in 2020 for <strong>AQP4-IgG+ Neuromyelitis Optica Spectrum Disorder (NMOSD)<\/strong>.<\/p>\n\n\n\n<p>In addition, Amgen is continuing its efforts to expand UPLIZNA\u2019s reach, with regulatory filings underway for <strong>generalized myasthenia gravis (gMG)<\/strong>, for which the drug has also been granted <strong>Orphan Drug Designation<\/strong>. Submission for gMG approval is expected to be completed in the first half of 2025.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-aldeyra-receives-fda-complete-response-letter-for-reproxalap-in-dry-eye-disease\"><span class=\"ez-toc-section\" id=\"Aldeyra_Receives_FDA_Complete_Response_Letter_for_Reproxalap_in_Dry_Eye_Disease\"><\/span>Aldeyra Receives FDA Complete Response Letter for Reproxalap in Dry Eye Disease<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Aldeyra Therapeutics announced that the FDA has issued a <strong>Complete Response Letter (CRL)<\/strong> for the <strong>resubmitted NDA<\/strong> of <strong>reproxalap<\/strong>, the company\u2019s investigational <a href=\"https:\/\/www.delveinsight.com\/report-store\/dry-eye-disease-market-insights\">treatment for <strong>dry eye disease<\/strong><\/a>. While no safety or manufacturing concerns were raised, the FDA concluded that the application lacked sufficient evidence of efficacy from \u201c<em>adequate and well-controlled studies<\/em>,\u201d particularly in addressing ocular symptoms. The agency requested at least <strong>one additional well-controlled trial<\/strong> demonstrating symptom relief before reproxalap can be considered for approval.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cThe CRL underscores the need to strengthen our clinical data package further,\u201d said <\/em><strong><em>Todd C. Brady, M.D., Ph.D.<\/em><\/strong><em>, President and CEO of Aldeyra. \u201cPending positive results from the ongoing clinical trials and continued dialogue with the FDA, we remain optimistic about a potential NDA resubmission by mid-2025.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>In response to prior FDA guidance, Aldeyra has been conducting <strong>three additional clinical trials<\/strong>\u2014two in controlled dry eye chambers and one six-week environmental exposure trial. The company achieved the <strong>primary endpoint<\/strong> in one of the chamber trials in August 2024 and resubmitted the NDA in October. The remaining trial results are expected in <strong>Q2 2025<\/strong>, with a <strong>Type A meeting<\/strong> scheduled in the coming weeks to address the FDA\u2019s latest feedback.<\/p>\n\n\n\n<p>As of December 31, 2024, Aldeyra reported $101 million in cash, cash equivalents, and marketable securities, with most trial-related costs already incurred in 2024. The expected 2025 trial expenses are approximately $6 million, positioning the company to move forward swiftly if results support another regulatory submission.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-fda-grants-accelerated-approval-to-novartis-vanrafia-for-proteinuria-in-iga-nephropathy\"><span class=\"ez-toc-section\" id=\"FDA_Grants_Accelerated_Approval_to_Novartis_Vanrafia_for_Proteinuria_in_IgA_Nephropathy\"><\/span>FDA Grants Accelerated Approval to Novartis&#8217; Vanrafia for Proteinuria in IgA Nephropathy<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Novartis has received <strong>accelerated approval from the FDA<\/strong> for <strong>Vanrafia (atrasentan)<\/strong>, a potent and selective <strong>endothelin A receptor antagonist<\/strong>, for the <a href=\"https:\/\/www.delveinsight.com\/report-store\/iga-nephropathy-igan-market\"><strong>reduction of proteinuria in adults with primary IgA nephropathy (IgAN)<\/strong><\/a> who are at risk of rapid disease progression. Vanrafia, a once-daily oral therapy, can be seamlessly integrated into supportive care regimens\u2014including use alongside RAS and SGLT2 inhibitors\u2014with <strong>no REMS requirement<\/strong>, simplifying access for patients and physicians.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cVanrafia offers a new option that can be easily added to current treatment plans, and its ability to reduce proteinuria early and consistently is critical for improving long-term outcomes in IgAN,\u201d said <\/em><strong><em>Dr. Richard Lafayette<\/em><\/strong><em>, Professor of Medicine at Stanford University and Steering Committee Member for the ALIGN study. \u201cThis approval represents meaningful progress for patients who previously had limited options and faced a high risk of progressing to kidney failure.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>The approval is based on <strong>interim results from the Phase III ALIGN trial<\/strong>, where Vanrafia achieved a <strong>36.1% reduction in proteinuria (P&lt;0.0001)<\/strong> compared to placebo at 36 weeks, with improvement seen as early as Week 6. A similar effect was observed in patients also receiving SGLT2 inhibitors. The safety profile was favorable, though clinicians are advised to monitor liver enzymes during treatment due to class-related risks. Importantly, while the current approval is for proteinuria reduction, full approval is contingent upon results from ongoing studies evaluating Vanrafia\u2019s impact on kidney function decline (eGFR) over 136 weeks, with data expected in 2026.<\/p>\n\n\n\n<p>This marks Novartis&#8217; <strong><em>third FDA renal approval in under a year<\/em><\/strong>, following FABHALTA approvals for C3G in March 2025 and IgAN in August 2024, further solidifying the company&#8217;s leadership in nephrology. Novartis is also advancing zigakibart, an anti-APRIL monoclonal antibody, currently in Phase III for IgAN, as part of its robust pipeline aimed at transforming outcomes across rare kidney diseases.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-biogen-s-tau-targeting-therapy-biib080-gets-fda-fast-track-for-alzheimer-s-treatment\"><span class=\"ez-toc-section\" id=\"Biogens_Tau-Targeting_Therapy_BIIB080_Gets_FDA_Fast_Track_for_Alzheimers_Treatment\"><\/span>Biogen&#8217;s Tau-Targeting Therapy BIIB080 Gets FDA Fast Track for Alzheimer\u2019s Treatment<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Biogen has announced that the <strong>FDA has granted Fast Track designation<\/strong> to <strong>BIIB080<\/strong>, its investigational <strong>antisense oligonucleotide (ASO) therapy<\/strong> targeting tau protein, for the <a href=\"https:\/\/www.delveinsight.com\/report-store\/alzheimers-disease-ad-market\">treatment of <strong>Alzheimer\u2019s disease<\/strong><\/a>. The designation underscores the urgent need for novel approaches that can address the complex biology of this progressive and fatal neurodegenerative condition.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cWe are encouraged by the FDA\u2019s Fast Track designation for BIIB080, which highlights the urgent need for innovative treatments targeting tau pathology in Alzheimer\u2019s disease,\u201d said <\/em><strong><em>Dr. Priya Singhal<\/em><\/strong><em>, Head of Development at Biogen. \u201cThis therapy represents a differentiated approach with promising potential. We are moving forward with urgency to help patients and families affected by this devastating disease.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>BIIB080 is the first ASO therapy targeting tau to enter clinical development for Alzheimer\u2019s and is currently being evaluated in the Phase II CELIA study, which is now fully enrolled. Previously reported Phase Ib data showed dose-dependent reductions in soluble tau in cerebrospinal fluid, decreases in aggregated tau on PET imaging, and favorable cognitive trends in exploratory outcomes\u2014suggesting a potential clinical benefit.<\/p>\n\n\n\n<p>With data from the CELIA trial expected in <strong>2026<\/strong>, BIIB080 adds to Biogen\u2019s diversified Alzheimer\u2019s portfolio and reflects its commitment to advancing therapies that target distinct pathological mechanisms in the disease.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-epicrispr-receives-fda-ind-clearance-for-epi-321-in-fshd-treatment\"><span class=\"ez-toc-section\" id=\"Epicrispr_Receives_FDA_IND_Clearance_for_EPI-321_in_FSHD_Treatment\"><\/span>Epicrispr Receives FDA IND Clearance for EPI-321 in FSHD Treatment<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Epicrispr Biotechnologies has announced <strong>FDA clearance of its Investigational New Drug (IND) application<\/strong> for <strong>EPI-321<\/strong>, a first-in-class epigenetic therapy for <a href=\"https:\/\/www.delveinsight.com\/report-store\/facioscapulohumeral-muscular-dystrophy-market\"><strong>facioscapulohumeral muscular dystrophy (FSHD)<\/strong><\/a> \u2014 a rare, progressive neuromuscular disorder with no approved treatments. The clearance comes shortly after <strong>regulatory approval in New Zealand<\/strong>, marking a key step in the company\u2019s <strong>global development strategy<\/strong>, with a <strong>Phase I\/II clinical trial expected to initiate in 2025<\/strong>.<\/p>\n\n\n\n<p>EPI-321 is designed as a one-time, gene-modulating therapy that uses a clinically validated AAV vector to silence the aberrant expression of the DUX4 gene, which plays a central role in FSHD by driving muscle degeneration. In preclinical models, EPI-321 showed robust DUX4 suppression and preservation of muscle tissue, supporting its potential to alter the course of the disease.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cThis milestone brings new hope to people living with FSHD,\u201d said <\/em><strong><em>Amber Salzman, Ph.D.<\/em><\/strong><em>, CEO of Epicrispr. \u201cEPI-321 is the first therapeutic candidate specifically designed to epigenetically silence DUX4, targeting the root cause of the disease. We\u2019re eager to bring this innovation to the clinic and to the patients who have waited far too long for treatment options.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>The therapy has already received <strong>Fast Track<\/strong>, <strong>Orphan Drug<\/strong>, and <strong>Rare Pediatric Disease designations<\/strong> from the FDA, reinforcing its potential to address a high unmet medical need.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><strong><em>Dr. Russell Butterfield<\/em><\/strong><em>, Associate Professor of Neurology and Pediatrics at the University of Utah, added: \u201cEPI-321 represents a novel and promising approach in FSHD, a disorder that has long lacked effective treatment. The upcoming U.S. trial is a significant step forward for patients and their families.\u201d<\/em><\/p>\n<\/blockquote>\n","protected":false},"excerpt":{"rendered":"<p>Amgen\u2019s UPLIZNA Becomes First FDA-Approved Treatment for IgG4-Related Disease Amgen announced that the FDA has approved UPLIZNA (inebilizumab-cdon) as the first and only treatment for adults with Immunoglobulin G4-related disease (IgG4-RD), a rare and chronic immune-mediated inflammatory condition that can affect multiple organ systems. The approval marks a significant milestone for patients living with IgG4-RD, [&hellip;]<\/p>\n","protected":false},"author":20,"featured_media":31439,"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":[72,204,18957,21570,21458,704,18841,18839,18838,349,420,639,5789],"industry":[17225],"therapeutic_areas":[17238,17230,17227,17245,17244],"class_list":["post-31438","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-alzheimers-disease","tag-delveinsight","tag-dry-eye-disease","tag-dry-eye-disease-market","tag-facioscapulohumeral-muscular-dystrophy","tag-fda","tag-iga-nephropathy","tag-iga-nephropathy-drug-pipeline","tag-iga-nephropathy-market","tag-latest-pharma-news","tag-news","tag-pharma-news","tag-recent-pharma-news","industry-pharmaceutical","therapeutic_areas-genetic-disorders","therapeutic_areas-genito-urinary-system-and-sex-hormones","therapeutic_areas-immunological-and-autoimmune-disorders","therapeutic_areas-neurology","therapeutic_areas-ophthalmology"],"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 | Amgen, Novartis, Biogen<\/title>\n<meta name=\"description\" content=\"Amgen\u2019s UPLIZNA First FDA Nod, Aldeyra\u2019s Reproxalap, Novartis\u2019 Vanrafia, Biogen\u2019s BIIB080, Epicrispr\u2019s EPI-321\" \/>\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-amgen-novartis-biogen\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pharma News | Amgen, Novartis, Biogen\" \/>\n<meta property=\"og:description\" content=\"Amgen\u2019s UPLIZNA First FDA Nod, Aldeyra\u2019s Reproxalap, Novartis\u2019 Vanrafia, Biogen\u2019s BIIB080, Epicrispr\u2019s EPI-321\" \/>\n<meta property=\"og:url\" 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