Kedrion Biopharma announced on September 29, 2025, that it has received FDA approval for QIVIGY (immune globulin intravenous [human]-kthm 10% liquid), marking a significant milestone as the company's first proprietary intravenous immune globulin (IVIG) therapy developed entirely in-house. The treatment is indicated for adults with primary humoral immunodeficiency (PI), a group of more than 550 rare disorders that compromise immune system function.
Clinical Trial Results Demonstrate Strong Efficacy
QIVIGY's approval was supported by a 12-month, open-label clinical study (NCT03961009) involving 47 adult patients with primary humoral immunodeficiency. The therapy achieved its primary efficacy endpoint with zero acute serious bacterial infections reported throughout the study period. Patients received intravenous infusions at doses ranging from 266 to 826 mg/kg every 3 or 4 weeks.
The study population had a median age of 56 years, with 64% being female and 96% White. Secondary outcomes further supported the therapy's effectiveness, showing an annualized rate of other infections of 2.1 per patient per year and zero hospitalizations due to infection during the study period.
"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," stated Nisha Jain, Vice President of Global Clinical Development at Kedrion.
Addressing Significant Unmet Medical Need
Primary immunodeficiency disorders affect an estimated 500,000 people in the United States, though the actual number may be significantly higher due to underdiagnosis and misdiagnosis. According to the Immune Deficiency Foundation, primary immunodeficiencies may affect as much as 1 to 2% of the population when all types and variations are considered.
These disorders leave individuals highly susceptible to recurrent infections, autoimmune complications, and other serious health challenges due to missing or impaired immune system components.
Safety Profile and Contraindications
The most common product-related adverse events observed in the clinical study included headache, infusion-related reactions, fatigue, nausea, and positive direct Coombs test results. QIVIGY carries warnings for potential blood clots, kidney dysfunction, and severe allergic reactions, particularly in patients with IgA deficiency who have antibodies against IgA.
The therapy is contraindicated in patients with a history of severe hypersensitivity to human immunoglobulin or those with IgA deficiency who have anti-IgA antibodies and hypersensitivity reactions.
Major Infrastructure Investment
Kedrion is making substantial financial commitments to support QIVIGY's commercialization and future growth. The company plans to invest over $260 million in developing more than 40 new U.S. plasma collection centers over the next several years. Additionally, Kedrion will invest over $60 million in capacity expansion projects at its Melville, NY manufacturing facility.
The company is also allocating $80 million for IT infrastructure and clinical studies, plus over $15 million specifically for QIVIGY's U.S. launch. These investments total more than $415 million in U.S. infrastructure expansion.
Commercial Launch and Global Expansion
QIVIGY is expected to be available in the United States in early 2026, with plans for global expansion in Europe and other markets following regulatory approvals. The therapy joins Kedrion's existing portfolio of 38 products across various therapeutic areas.
"2025 has been a year of meaningful transformation for Kedrion, and QIVIGY marks a pivotal accomplishment. As our first product approval since rebranding in April, it reflects the company that we are becoming, more focused, more connected, and more committed to patients," said Bob Rossilli, Global Chief Commercial Officer and U.S. General Manager.
CEO Ugo Di Francesco emphasized the significance of this achievement: "Seeing QIVIGY receive FDA approval is a deeply meaningful moment for all of us at Kedrion. This achievement is the result of years of vision, planning, and relentless dedication from countless employees, both current and previous."
The approval represents the culmination of over 10 years of internal research and development efforts, positioning Kedrion as both a manufacturer and branded innovator in the plasma-derived therapeutics space.
