Kedrion Biopharma Secures FDA Approval for Qivigy, Announces Major U.S. Investment Plans

Italian plasma specialist Kedrion Biopharma has received FDA approval for Qivigy, a new treatment for adults with primary humoral immunodeficiency (PI). The company has simultaneously unveiled ambitious plans to expand its presence in the United States, signaling a significant shift in its strategic focus.

FDA Approval and Clinical Trial Success

Qivigy, an intravenous immunoglobulin (IVIG) therapy, has been approved based on a successful clinical trial involving 47 patients. The study met its primary endpoint, with no acute bacterial infections recorded in treated patients over a 12-month period. Secondary outcomes were equally promising, with a low annual infection rate of 2.1 infections per patient on average, none of which resulted in hospitalization.

Dr. Nisha Jain, VP of global clinical development at Kedrion, emphasized the impact of the treatment: "For individuals living with primary immunodeficiency, the absence of serious bacterial infections means fewer disruptions to daily life, which in turn, means less time away from school and work due to hospitalizations."

Common adverse events reported during the trial included headache, infusion-related reactions, fatigue, and nausea.

Expansive U.S. Investment Strategy

Coinciding with the FDA approval, Kedrion has announced a comprehensive investment plan for the United States market. The company intends to inject more than $260 million into expanding its U.S. network, which includes the establishment of over 40 new plasma collection centers.

Additionally, Kedrion will allocate:

• $60 million for expanding capacity at its Melville, New York manufacturing facility
• $80 million for IT infrastructure and clinical trials
• $15 million for the U.S. launch of Qivigy, expected in early 2026

Bob Rossilli, Kedrion's chief commercial officer and U.S. general manager, stated, "Kedrion's strategic direction is to continue expanding in the United States to meet the growing demand for rare disease therapies."

Market Implications and Company Growth

The approval of Qivigy marks a significant milestone for Kedrion, representing the company's evolution "from manufacturer to researcher, developer and branded innovator." This development is particularly noteworthy as Qivigy is the first product in Kedrion's portfolio to be developed entirely in-house, setting it apart from the company's 38 other global offerings.

Kedrion's recent financial performance underscores its growth trajectory, with reported sales of 1.58 billion euros ($1.7 billion) in 2024, marking a 10% increase from the previous year. The company, which rebranded in 2020 from its original name Kedplasma GmbH, has positioned itself to capitalize on the expanding market for rare disease treatments, particularly in the United States.

With approximately 500,000 individuals living with PI in the U.S. – and potentially more due to underdiagnosis – Kedrion's strategic investments and the introduction of Qivigy could significantly impact the treatment landscape for this group of over 550 rare disorders.