Kedrion Biopharma Scores 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 Results

Qivigy, an intravenous immunoglobulin (IVIG) therapy, is designed to provide patients with antibodies to help combat infections. The FDA's decision was based on a 12-month trial involving 47 patients who received infusions every three or four weeks. The study met its primary endpoint, with no acute bacterial infections reported in treated patients. Secondary findings showed a low annual rate of 2.1 infections per patient on average, none of which resulted in hospitalization.

Dr. Nisha Jain, Kedrion's VP of global clinical development, emphasized the impact of the treatment, stating, "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.

Expansion Plans and U.S. Investment

In conjunction with the FDA approval, Kedrion Biopharma announced extensive investment plans in the United States:

• Over $260 million to expand its U.S. network with more than 40 new plasma collection centers
• More than $60 million to increase capacity at its manufacturing facility in Melville, New York
• $80 million for IT infrastructure and clinical trials
• $15 million allocated for the U.S. launch of Qivigy, expected in early 2026

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

Company Growth and Market Position

Kedrion Biopharma, established in 2001 and rebranded in 2020, reported sales of 1.58 billion euros ($1.7 billion) in 2024, marking a 10% increase from the previous year. The development of Qivigy represents a significant milestone for the 24-year-old company, as it was developed entirely in-house, demonstrating Kedrion's "growing capabilities from manufacturer to researcher, developer and branded innovator."

The approval of Qivigy addresses a significant market need, with approximately 500,000 people in the U.S. living with PI. The company notes that this number is likely higher due to underdiagnosis, as PI encompasses more than 550 rare disorders that leave individuals susceptible to recurrent infections and autoimmune complications.