Kedrion Biopharma has announced the U.S. launch of YIMMUGO (Immune Globulin Intravenous, Human-dira, 10%), marking a significant advancement in the company’s growing American product portfolio. This milestone reflects Kedrion’s ongoing commitment to expanding access to innovative and life-changing therapies for individuals living with primary immunodeficiency (PI).
Originally introduced in Europe in 2022, YIMMUGO received approval from the U.S. Food and Drug Administration (FDA) on June 13, 2024, for the treatment of PI in patients aged two years and older. The therapy, developed by Biotest AG, part of the Grifols Group, is a next-generation, highly purified 10% intravenous immunoglobulin (IVIG) product designed to provide reliable and effective immune support. In 2024, Biotest AG granted Kedrion Biopharma exclusive rights to commercialize YIMMUGO in the United States, further strengthening Kedrion’s position in the U.S. immunoglobulin market.
Primary immunodeficiency (PI) encompasses more than 550 rare and chronic immune system disorders that impair the body’s ability to fight infections. People living with PI often experience recurring infections, autoimmune complications, and long-term health challenges. The condition affects an estimated 500,000 individuals in the United States and approximately 6 million people worldwide. However, experts believe these numbers are conservative, as PI frequently goes undiagnosed or misdiagnosed, leaving many patients without proper treatment or support.
As the demand for effective therapies continues to rise—driven by greater awareness, improved diagnostic capabilities, and growing patient needs—YIMMUGO enters the U.S. market as a timely and impactful treatment option. Kedrion Biopharma’s launch strategy focuses on patient-centered care, ensuring availability through specialized distribution networks and healthcare partnerships.
“We are executing a bold, patient-first strategy to strengthen and diversify our immunoglobulin portfolio,” said Bob Rossilli, Chief Commercial Officer and U.S. General Manager at Kedrion Biopharma. “With our expertise, agility, and dedication to improving the lives of patients and supporting healthcare providers, we are well positioned to make a significant difference in the IVIG space and beyond.”
