Kedrion Biopharma To Market Immunoglobulin therapy Yimmugo in US

Kedrion Biopharma Inc., a biopharmaceutical firm, declared that it has established the framework for a long-term partnership with Biotest AG for the complete commercialization and marketing of the immunoglobulin therapy Yimmugo in the United States, following the FDA's approval of the Biologic License Application (BLA) on June 13, 2024.

Immunoglobulin treatments, such as Yimmugo, are critical for treating primary immunodeficiencies (PID), which afflict about 500,000 persons in the United States. They have an important role in infection prevention, immune function enhancement, and patient quality of life improvement.

"Kedrion is proud of our role in addressing rare immune system deficiencies by making Yimmugo accessible to patients in the US," said Ugo Di Francesco, CEO of Kedrion Biopharma. "Biotest has been an excellent collaborator, and we look forward to exploring further opportunities. This significant new arrangement is part of our larger strategy to address unmet patient needs in antibody immunodeficiency."

Kedrion, which presently distributes two of the fastest-growing injectable immunoglobulin (IG) medicines in the United States, is well-positioned for Yimmugo's successful commercialization and distribution. Subject to the finalization of the definitive long-term agreement, Biotest expects to begin selling Yimmugo to Kedrion in Q4 2024, with a market launch anticipated for Q1 2025.

The US IG market is predicted to expand by around 9% per year over the next eight years, indicating an increasing patient demand for the medicine. By distributing Yimmugo, Kedrion can continue to address this market demand and serve a larger section of the PID patient community.