Kedrion Biopharma Receives FDA Approval for QIVIGY® (Immune Globulin 10% IV) for treatment of Primary Humoral Immunodeficiency in Adults and confirms its plan to increase investments in the U.S. throughout its global operations.

• QIVIGY is the realization of over 10 years of investments and internal efforts to bring a proprietary IVIG product from concept to commercialization 

FORT LEE, N.J., Sept. 29, 2025 /PRNewswire/ -- Kedrion Biopharma announced today that it has received FDA approval for QIVIGY immune globulin intravenous (human)-kthm 10% liquid, indicated for treatment of adults with primary humoral immunodeficiency (PI)—a serious and often underdiagnosed group of disorders that compromise the immune system's ability to function effectively. QIVIGY, a 10% IVIG therapy, developed in Kedrion's research labs and produced exclusively by Kedrion through its globally integrated network of facilities in the United States and Italy, addresses the unmet needs of patients with PI. 

Ugo Di Francesco, Kedrion's Chief Executive Officer commented: "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." Di Francesco went on to add: "It reflects not only our scientific and operational capabilities, but also the heart and purpose that drive our mission to serve patients. Today, we celebrate two success stories: one in the delivery of a product that helps improve patient care and another that defines us as an organization, demonstrating our ability to deliver while also illuminating the path ahead."

QIVIGY's efficacy and safety were evaluated in a 12-month clinical study in adults with PI. The therapy achieved its primary endpoint, with no acute serious bacterial infections reported. Secondary outcomes demonstrated a low rate of other infections, no infection-related hospitalizations, and minimal disruption to daily activities. The most common product-related adverse events included headache, infusion-related reactions, fatigue, nausea, and positive direct Coombs test results. 

"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. This outcome reflects our dedication to delivering therapies that truly support patients' health and well-being." stated Nisha Jain, Vice President, Global Clinical Development.

Primary immunodeficiency disorders (PID) encompass more than 550 rare, chronic disorders in which components of the immune system are either missing or impaired, leaving individuals highly susceptible to recurrent infections, autoimmune complications, and other serious health challenges. 

An estimated 500,000 people in the U.S. are currently living with PID, though the true number may be significantly higher due to underdiagnosis and / or misdiagnosis. According to the Immune Deficiency Foundation (IDF), primary immunodeficiencies may affect as much as 1 to 2% of the population when all types and variations are considered—highlighting the urgent need for greater awareness, earlier detection, and expanded access to effective therapies.

"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. We're evolving with purpose, raising awareness, and bringing our values to life. This is just a step along a journey toward something great, and I'm excited to be a part of it, to celebrate this occasion, and to begin working on our next endeavor." said Bob Rossilli, Global Chief Commercial Officer and U.S. General Manager.

With QIVIGY, Kedrion is adding another IVIG treatment option for patients and healthcare providers to its broad suite of therapies designed to meet the diverse needs of patients. QIVIGY holds a distinct position in Kedrion's growing portfolio as a brand to be developed from concept to commercialization exclusively by Kedrion. QIVIGY will join their existing global portfolio of 38 products across various therapeutic areas. This achievement demonstrates the depth and breadth of Kedrion's growing capabilities from manufacturer to researcher, developer and branded innovator.

Kedrion' s commitment to its Global and U.S. infrastructure as well as lifecycle management for QIVIGY includes ongoing research and development activities aimed at identifying new opportunities to meet the unmet needs of broader patient populations with rare immunological and neurological conditions, as well as long-term investments in manufacturing facilities and capacity expansion to support growth. Kedrion's financial commitment to QIVIGY encompasses every phase of its production, starting from increasing its U.S. plasma collection network by investing over $260 million in developing over 40 new U.S. collection centers over the next several years. As plasma collection efforts accelerate, manufacturing capacity must keep pace. To support this growth, Kedrion is planning to invest over $60 million in capacity expansion projects at its Melville, NY manufacturing facility, while simultaneously expanding capacity globally. In addition, Kedrion is investing an additional $80 million to be spent on IT infrastructure and clinical studies as well as over $15 million to launch QIVIGY in the U.S.

"Kedrion's commitment to global growth with a specific focus on the U.S. is impressive and doesn't stop with QIVIGY. Kedrion will continue to grow its new product development programs, with significant capex investments over the next few years. Kedrion's strategic direction is to continue expanding in the United States to meet the growing demand for rare disease therapies" said Rossilli.

QIVIGY will be launched in the U.S. first, with plans for global expansion in Europe and other markets upon approval. This growth will be possible because of the strength of Kedrion's supply chain infrastructure and the expansion of its distribution network to ensure greater access for patients and providers across global markets.

QIVIGY is expected to be available in the U.S. in early 2026.

IMPORTANT SAFETY INFORMATION

QIVIGY may cause:

• Blood clots (thrombosis). Blood clots may occur in people taking Ig intravenous (IGIV) products, including QIVIGY. You may be at greater risk for blood clots if you are older, sit or lie for long periods, have a clotting problem or history of blood clots, take estrogen, have a central catheter, have thick blood, and/or if you have other conditions that put you at risk for cardiovascular disease. Blood clots may occur even if you do not have any of these risk factors. Your healthcare provider will monitor you for signs and symptoms of blood clotting.
• Impaired kidney function or kidney failure. IGIV products have been associated with kidney dysfunction and damage, kidney failure, and death. You may be at greater risk for kidney failure if you have kidney disease, diabetes, are over 65, are seriously dehydrated, overweight, have certain infections like sepsis, have a condition that causes abnormal proteins in your blood, or take drugs that may damage your kidneys. Your healthcare provider will monitor your kidney function before and periodically after your first infusion.

Do NOT use QIVIGY if:

• You have a history of severe hypersensitivity or a history of allergic reactions to human Ig. Tell your healthcare provider if you have had a serious reaction to other medicines that contain human Ig or ask if you are not sure.
• You have an immunoglobulin A (IgA) deficiency, have antibodies to IgA, and have a hypersensitivity or a history of allergic reactions. Tell your healthcare provider if you have an IgA deficiency or ask if you are not sure.

WARNINGS AND PRECAUTIONS

• Severe allergic reactions may occur. People with IgA deficiency who have antibodies against IgA may be at greater risk of these reactions.
• You could experience higher-than-normal levels of protein in your blood, thick blood, or low sodium (salt) in your blood. This may prevent your blood from flowing easily and possibly lead to blood clots.
• Brain swelling called aseptic meningitis syndrome may occur with IGIV products, especially if you receive a high dose or a rapid infusion.
• Blood damage called hemolysis and hemolytic anemia can develop after treatment with QIVIGY. Your healthcare provider will monitor you for signs and symptoms.
• Swelling of the lungs may occur following treatment. Your healthcare provider will monitor you for signs of lung damage.
• QIVIGY is made from human blood and may contain infectious agents, eg, viruses and, theoretically, the Creutzfeldt-Jakob disease agent.
• Be sure to tell your healthcare provider about your recent history of vaccinations. Live vaccines for diseases like measles, mumps, rubella, and varicella may not work as well while receiving QIVIGY. Tell your healthcare provider that you are taking QIVIGY before you receive any vaccination.

ADVERSE REACTIONS

The most common side effects of QIVIGY were headache, fatigue, infusion-related reaction, positive direct Coombs test result suggesting the immune system is attacking the body's red blood cells, nausea, sinus inflammation, dizziness, and diarrhea. During treatment with QIVIGY, be sure to tell your healthcare provider about any unusual symptoms you experience, as they may indicate a possible side effect.

To report SUSPECTED ADVERSE REACTIONS, contact Kedrion Biopharma Inc. at 1-855-3KDRION

(1-855-353-7466) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

About the clinical study:

The efficacy of QIVIGY was evaluated in an open-label, prospective clinical study in adult patients with primary humoral immunodeficiency (NCT03961009). A total of 47 patients received intravenous infusion of QIVIGY at the dose of 266 to 826 mg/kg every 3 or 4 weeks for 12 months. Thirty-nine and 8 patients were administered QIVIGY on a 4-week or a 3-week infusion cycle, respectively. 

The population characteristics were as follows: The median age was 56 years (range 20 to 70 years), 30 patients (64%) were female, 45 patients (96%) were White, and 2 patients (4%) were of "other" race.

The primary efficacy outcome was the incidence rate of acute serious bacterial infections (SBIs; bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, visceral abscess, and osteomyelitis/septic arthritis). Secondary efficacy outcomes included the incidence rate of infections other than acute SBIs, patients hospitalized due to infection, number and duration of antibiotic treatment for any kind of infection and missed work/school/other major activities due to infections.

QIVIGY met the study's primary efficacy endpoint, with zero acute serious bacterial infections reported over the 12-month study period. In addition, the annualized rate of other infections was 2.1 infections per patient per year, and zero PI patients were hospitalized due to infection during the study. The most common product-related adverse events observed in ≥ 5% of clinical study subjects were headache, infusion-related reaction, Coombs direct test positive, fatigue, and nausea. 

About Kedrion Biopharma

Kedrion Biopharma collects and fractionates blood plasma to produce and distribute plasma-derived therapies for rare, ultra-rare, and debilitating conditions like Coagulation and Neurological Disorders, Immunodeficiencies, and Rh sensitization. We employ approximately 5,200 people worldwide and our industrial network includes 68 plasma collection centers in the United States and 8 in the Czech Republic, and 7 production facilities across 5 countries. We are committed to creating a world where science and care know no bounds, partnering with the medical-scientific community, institutions, patient advocacy groups, and research bodies to foster innovation and improve care. Every connection we make impacts someone, somewhere.

Forward Looking Statements:

This release includes "forward-looking statements," within the meaning of the securities laws and certain other jurisdictions, based on current expectations and projections about future events. All statements other than statements of historical facts included in this release, including, without limitation, statements regarding our future financial position, risks and uncertainties related to our business, strategy, capital expenditures and our plans and objectives for future operations, may be deemed to be forward-looking statements. These forward-looking statements are subject to a number of risks and uncertainties. Words such as "believe," "expect," "anticipate," "may," "assume," "plan," "intend," "will," "should," "estimate," "risk," "target," "objectives," "outlook," "probably," "project," "seek" and similar expressions or the negatives of these expressions are intended to identify forward-looking statements. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. Any forward-looking statement speaks only as of the date on which it is made and we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

CONTACT: Jennifer Donegan, [email protected] 

SOURCE Kedrion Biopharma