Kedrion Biopharma has received approval in the United States for a new 10% intravenous Immunoglobulin intended for the treatment of Primary Immunodeficiencies in adults.
The new therapy was developed in Kedrion’s research laboratories and will be produced exclusively by the company through its integrated network of facilities in the United States and Italy. Clinical trial results have shown that patients treated with this therapy can expect fewer infections, offering a tangible benefit to their quality of life.
The development of this product was made possible thanks to significant investments in Italy, including the production facility in Castelvecchio Pascoli, in the province of Lucca: a nearly 2,000-square-meter plant dedicated to Immunoglobulin purification. Production is carried out in an integrated manner across Kedrion’s global facilities – fractionation in Melville (USA), purification in Castelvecchio Pascoli, and filling in Bolognana, both in the province of Lucca – meaning a key part of the process takes place in Tuscany, confirming Italy’s central role in the company’s global strategy.
This marks a significant step in the company’s global growth journey, which also includes plans for the future expansion of this product into other international markets, including Italy and Europe, once the necessary approvals are obtained.
Primary Immunodeficiencies include over 550 rare and chronic conditions, often little known, that impair the immune system’s ability to protect the body. Kedrion’s new 10% intravenous Immunoglobulin is indicated for the treatment of these conditions, offering a new therapeutic solution for affected patients. Kedrion has always been committed to raising awareness among the public and the scientific community about these diseases, promoting greater understanding and access to therapies.
Kedrion is evolving with a clear purpose: to bring its values to life, further strengthening its role as a responsible company attentive to patients’ needs. Our mission is driven by the desire to improve the quality of life for people affected by rare and ultra-rare diseases, through continuous investment in research, development, and production.
“This 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,” explains Ugo Di Francesco, CEO of Kedrion. “We are proud to reinforce our role as an Italian company looking to the United States and the world, investing in research to help more and more people affected by rare and ultra-rare diseases. Plasma is a precious and irreplaceable resource 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 new therapies and offering hope to those who need it most.”
The new 10% intravenous Immunoglobulin joins a global portfolio of 38 products across various therapeutic areas, a testament to Kedrion’s strength and diversification as an Italian company with an international vision. This achievement demonstrates the depth and breadth of Kedrion’s capabilities: from manufacturer to researcher, developer, and innovator, with an integrated supply chain that enhances Italian know-how and collaboration among our facilities worldwide.
Kedrion’s research and development activities are constantly focused on identifying new therapeutic opportunities for patients with rare conditions, especially immunological, neurological, and coagulation disorders, with a particular focus on orphan drugs and innovation rooted in Italy.
“I 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,” said Paolo Marcucci, Chairman of Kedrion. “A journey that has been carried forward with professionalism, vision, and determination by CEO Ugo Di Francesco, to whom I extend my sincere thanks. This shared commitment today translates into a concrete therapy for patients affected by a rare disease, who increasingly need targeted and effective solutions.”
Looking ahead, Kedrion will continue to invest in innovation, sustainability, and growth, with the goal of offering solutions to patients around the world and making a tangible contribution to the advancement of healthcare.