• 01 Oct 2025
• Admin
• News Article

Kedrion Biopharma Secures FDA Approval for Qivigy™, a New 10% IVIG Therapy for Primary Immunodeficiency

Kedrion Biopharma today announced that the U.S. Food and Drug Administration (FDA) has approved Qivigy™ (10% intravenous immunoglobulin) for the treatment of adults with primary humoral immunodeficiency (PI), a group of serious and often underdiagnosed disorders that compromise immune function.

This approval marks Kedrion’s first FDA approval since its April rebrand and underscores the company’s evolution into a fully integrated, innovation-driven biopharma leader.

About Qivigy™

• Therapy type: 10% intravenous immunoglobulin (IVIG)
• Indication: Adults with primary humoral immunodeficiency (PI)
• Benefits: Clinical outcomes demonstrated fewer infections and reduced time lost from school and work
• Development & Production: Conceived in Kedrion’s research labs and manufactured exclusively by Kedrion in its U.S. and Italian facilities

Qivigy is expected to be available in the U.S. in early 2026, with global launches in Europe and other markets pending approvals.

Executive Commentary

• Ugo Di Francesco, CEO: “FDA approval for Qivigy is a deeply meaningful moment for Kedrion. It reflects our scientific capabilities and our mission to serve patients worldwide.”
• Bob Rossilli, Global CCO & US GM: “As our first approval since rebranding, Qivigy defines who we are becoming—more focused, connected, and committed. This is a milestone on our journey to transform rare disease care.”

The Unmet Need in PI

• Scope: Over 550 rare, chronic disorders classified as primary immunodeficiency
• Impact in U.S.: ~500,000 diagnosed patients; true prevalence may reach 1–2% of the population due to underdiagnosis
• Patient risks: Frequent infections, autoimmune complications, and long-term health challenges
• Urgency: Expanded access and earlier detection remain critical needs

Kedrion’s Growth & Investments

To ensure global availability of Qivigy and support long-term rare disease innovation, Kedrion is investing heavily in infrastructure and R&D:

• Plasma supply: $260M to open 40+ new U.S. plasma collection centers
• Manufacturing: $60M for U.S. capacity expansion at Melville, NY
• R&D & IT: $80M in infrastructure and clinical studies
• Launch investments: $15M allocated to U.S. product launch activities

Kedrion currently offers a portfolio of 38 therapies across immunological, neurological, and hematological conditions. Qivigy will strengthen its leadership in plasma-derived rare disease treatments.

About Kedrion Biopharma

Kedrion Biopharma is a global plasma-derived therapies company that develops, manufactures, and distributes treatments for rare and ultra-rare conditions including immunodeficiencies, neurological disorders, coagulation disorders, and Rh sensitization. With a globally integrated network spanning the United States and Europe, Kedrion is committed to innovation, patient care, and expanding access to life-saving therapies.