#United States #FDA Approval #Fort Lee #Kedrion Biopharma #QIVIGY

Kedrion Biopharma Achieves FDA Approval for QIVIGY®

Kedrion Biopharma, a notable player in the biopharmaceutical field, has recently announced the FDA approval of its product QIVIGY, an immune globulin intravenous (IVIG) solution aimed at treating adults with primary humoral immunodeficiency (PI). This milestone represents the culmination of over a decade of rigorous research, investment, and commitment to developing effective treatments for individuals facing significant health challenges due to compromised immune systems.

Understanding Primary Humoral Immunodeficiency

Primary humoral immunodeficiency disorders are a collection of over 550 rare diseases that hinder the immune system's ability to function normally, leaving individuals vulnerable to repeated infections, autoimmune diseases, and other serious health complications. The impact of these disorders is profound, affecting an estimated 500,000 people in the United States alone, with many cases likely undiagnosed. QIVIGY is designed to meet the critical need for effective therapies in this area, providing a new option for patients who previously had limited treatment avenues.

Product Efficacy and Clinical Trials

The efficacy and safety of QIVIGY were established through an extensive 12-month clinical trial involving adult participants diagnosed with PI. The key findings from the trial showcased that QIVIGY successfully met its primary endpoint, achieving zero instances of acute serious bacterial infections during the study period. Additionally, secondary outcomes were promising, reflecting a low rate of other infections and no hospitalizations due to these infections. Common adverse effects reported included headache, fatigue, and infusion-related reactions, underscoring the product's safety for most patients.

Ugo Di Francesco, CEO of Kedrion Biopharma, expressed the significance of this achievement, noting, "Seeing QIVIGY receive FDA approval is a deeply meaningful moment for all of us at Kedrion. This milestone is indicative of our enduring commitment to advance patient care and reflects the tireless efforts of our dedicated employees."

Strategic Growth and Investment Plans

Kedrion's commitment to addressing the needs of patients extends beyond the launch of QIVIGY. The company has unveiled an ambitious plan to invest more than $260 million into establishing over 40 new U.S. plasma collection centers over the coming years. This initiative aims to enhance the supply of critical raw materials for manufacturing its immune globulin therapies, including QIVIGY. Moreover, an additional $60 million will be allocated for expanding production facilities in Melville, New York, along with investments in IT infrastructure and clinical studies.

Bob Rossilli, Global Chief Commercial Officer, emphasized Kedrion's determination to expand its U.S. presence and meet the rising demand for therapies designed specifically for rare diseases. He remarked, "2025 marks a year of transformation for Kedrion, and the approval of QIVIGY epitomizes our evolving commitment to improving patient outcomes."

Launch and Future Prospects

QIVIGY is set to launch in the United States in early 2026, with aspirations for global expansion into European markets and beyond as the product receives further approvals. This strategic rollout is underpinned by the robust supply chain and distribution network that Kedrion is actively enhancing to facilitate broader access for patients across the globe.

Kedrion is proud to pioneer advancements in treating immune deficiencies, standing as a beacon of hope for individuals grappling with these challenging conditions. The approval of QIVIGY is more than just a business milestone; it is a testament to Kedrion’s unwavering dedication to transforming lives and fostering health equality worldwide. As more patients gain access to QIVIGY and future therapies, the possibility of a healthier life for individuals with primary immunodeficiencies becomes a palpable reality.