{"id":8890,"date":"2025-10-08T16:36:22","date_gmt":"2025-10-08T14:36:22","guid":{"rendered":"https:\/\/www.kedrion.it\/?post_type=news&#038;p=8890"},"modified":"2025-10-08T16:36:24","modified_gmt":"2025-10-08T14:36:24","slug":"kedrion-receives-us-approval-for-new-10-intravenous-immunoglobulin-the-result-of-italian-investment-and-know-how","status":"publish","type":"news","link":"https:\/\/www.kedrion.it\/en\/kedrion-receives-us-approval-for-new-10-intravenous-immunoglobulin-the-result-of-italian-investment-and-know-how\/","title":{"rendered":"Kedrion receives US approval for new 10% intravenous Immunoglobulin, the result of Italian investment and know-How"},"content":{"rendered":"\n<!--more-->\n\n\n\n<p><strong>Kedrion Biopharma<\/strong> has received <strong>approval in the United States<\/strong> for a new <strong>10% intravenous Immunoglobulin<\/strong> intended for the treatment of <strong>Primary Immunodeficiencies in adults<\/strong>.<\/p>\n\n\n\n<p>The new therapy was developed in <strong>Kedrion\u2019s research laboratories<\/strong> and will be produced exclusively by the company through its <strong>integrated network of facilities<\/strong> in the United States and Italy. Clinical trial results have shown that patients treated with this therapy can expect <strong>fewer infections<\/strong>, offering a tangible benefit to their <strong>quality of life<\/strong>.<\/p>\n\n\n\n<p>The development of this product was made possible thanks to <strong>significant investments in Italy<\/strong>, including the <strong>production facility in Castelvecchio Pascoli<\/strong>, in the province of Lucca: a nearly 2,000-square-meter plant dedicated to <strong>Immunoglobulin purification<\/strong>. Production is carried out in an integrated manner across Kedrion\u2019s global facilities \u2013 <strong>fractionation in Melville (USA)<\/strong>, <strong>purification in Castelvecchio Pascoli<\/strong>, and <strong>filling in Bolognana<\/strong>, both in the province of Lucca \u2013 meaning a key part of the process takes place in <strong>Tuscany<\/strong>, confirming <strong>Italy\u2019s central role<\/strong> in the company\u2019s global strategy.<\/p>\n\n\n\n<p>This marks a <strong>significant step<\/strong> in the company\u2019s global growth journey, which also includes plans for the <strong>future expansion<\/strong> of this product into other international markets, including <strong>Italy and Europe<\/strong>, once the necessary approvals are obtained.<\/p>\n\n\n\n<p><strong>Primary Immunodeficiencies<\/strong> include over 550 rare and chronic conditions, often little known, that impair the immune system\u2019s ability to protect the body. Kedrion\u2019s new <strong>10% intravenous Immunoglobulin<\/strong> is indicated for the treatment of these conditions, offering a <strong>new therapeutic solution<\/strong> for affected patients. Kedrion has always been committed to <strong>raising awareness<\/strong> among the public and the scientific community about these diseases, promoting <strong>greater understanding and access to therapies<\/strong>.<\/p>\n\n\n\n<p><strong>Kedrion is evolving with a clear purpose<\/strong>: to bring its values to life, further strengthening its role as a <strong>responsible company<\/strong> attentive to <strong>patients\u2019 needs<\/strong>. Our mission is driven by the desire to <strong>improve the quality of life<\/strong> for people affected by <strong>rare and ultra-rare diseases<\/strong>, through continuous investment in <strong>research, development, and production<\/strong>.<\/p>\n\n\n\n<p>\u201cThis recognition is a concrete example of how Kedrion intends to continue building its future, leveraging know-how developed over time and the legacy of decades in the plasma-derived sector,\u201d explains <strong>Ugo Di Francesco<\/strong>, <strong>CEO of Kedrion<\/strong>. \u201cWe are proud to reinforce our role as an <strong>Italian company<\/strong> looking to the <strong>United States and the world<\/strong>, investing in research to help more and more people affected by <strong>rare and ultra-rare diseases<\/strong>. <strong>Plasma is a precious and irreplaceable resource<\/strong> for treating these conditions, and Kedrion is investing with determination in research to explore all the potential of this raw material, with the goal of developing <strong>new therapies<\/strong> and offering <strong>hope to those who need it most<\/strong>.\u201d<\/p>\n\n\n\n<p>The new <strong>10% intravenous Immunoglobulin<\/strong> joins a <strong>global portfolio of 38 products<\/strong> across various therapeutic areas, a testament to Kedrion\u2019s <strong>strength and diversification<\/strong> as an <strong>Italian company with an international vision<\/strong>. This achievement demonstrates the <strong>depth and breadth<\/strong> of Kedrion\u2019s capabilities: from <strong>manufacturer to researcher, developer, and innovator<\/strong>, with an <strong>integrated supply chain<\/strong> that enhances <strong>Italian know-how<\/strong> and collaboration among our facilities worldwide.<\/p>\n\n\n\n<p>Kedrion\u2019s <strong>research and development activities<\/strong> are constantly focused on identifying <strong>new therapeutic opportunities<\/strong> for patients with <strong>rare conditions<\/strong>, especially <strong>immunological, neurological<\/strong>, and <strong>coagulation disorders<\/strong>, with a particular focus on <strong>orphan drugs<\/strong> and <strong>innovation rooted in Italy<\/strong>.<\/p>\n\n\n\n<p>\u201cI am especially pleased to see the results of years of investment that Kedrion has pursued with conviction come to life today with the approval of this product, together with the investors and institutions of this country who have supported us along the way,\u201d said <strong>Paolo Marcucci<\/strong>, <strong>Chairman of Kedrion<\/strong>. \u201cA journey that has been carried forward with <strong>professionalism<\/strong>, vision, and determination by <strong>CEO<\/strong> <strong>Ugo Di Francesco<\/strong>, to whom I extend my sincere thanks. This shared commitment today translates into a <strong>concrete therapy<\/strong> for patients affected by a <strong>rare disease<\/strong>, who increasingly need <strong>targeted and effective solutions<\/strong>.\u201d<\/p>\n\n\n\n<p>Looking ahead, <strong>Kedrion will continue to invest<\/strong> in <strong>innovation, sustainability, and growth<\/strong>, with the goal of offering <strong>solutions<\/strong> to patients around the world and making a <strong>tangible contribution to the advancement of healthcare<\/strong>.<\/p>\n","protected":false},"featured_media":8889,"template":"","categories_news":[45],"class_list":["post-8890","news","type-news","status-publish","has-post-thumbnail","hentry","categories_news-corporate-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Kedrion receives US approval for new 10% intravenous Immunoglobulin, the result of Italian investment and know-How - Kedrion Biopharma<\/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.kedrion.it\/en\/kedrion-receives-us-approval-for-new-10-intravenous-immunoglobulin-the-result-of-italian-investment-and-know-how\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Kedrion receives US approval for new 10% intravenous Immunoglobulin, the result of Italian investment and know-How - Kedrion Biopharma\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.kedrion.it\/en\/kedrion-receives-us-approval-for-new-10-intravenous-immunoglobulin-the-result-of-italian-investment-and-know-how\/\" \/>\n<meta property=\"og:site_name\" content=\"Kedrion Biopharma\" \/>\n<meta property=\"article:modified_time\" content=\"2025-10-08T14:36:24+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.kedrion.it\/wp-content\/uploads\/2025\/10\/foto-Kedrion-Biopharma-1024x683.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1024\" \/>\n\t<meta property=\"og:image:height\" content=\"683\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.kedrion.it\/en\/kedrion-receives-us-approval-for-new-10-intravenous-immunoglobulin-the-result-of-italian-investment-and-know-how\/\",\"url\":\"https:\/\/www.kedrion.it\/en\/kedrion-receives-us-approval-for-new-10-intravenous-immunoglobulin-the-result-of-italian-investment-and-know-how\/\",\"name\":\"Kedrion receives US approval for new 10% intravenous Immunoglobulin, the result of Italian investment and know-How - 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