Kedrion Activates Nationwide Distribution Network for QIVIGY® in the U.S.

A national distribution network with robust reach enables broad access to QIVIGY across specialty pharmacies, infusion centers, hospitals, and other sites of care nationwide

FORT LEE, N.J., March 6, 2026 /PRNewswire/ — Today Kedrion Biopharma announced the nationwide commercial availability of QIVIGY, its FDA‑approved 10% Intravenous Immunoglobulin (IVIG) therapy, through a broad U.S. distribution model designed to serve healthcare customers across specialty pharmacies, infusion centers, hospitals, and other sites of care. The launch is supported by key distribution partners and aligned group purchasing organization (GPO) relationships, providing the commercial infrastructure needed to support consistent supply, efficient ordering, and scalable access across the IVIG market.

Approved by the U.S. Food and Drug Administration in late 2025, QIVIGY is Kedrion’s first fully proprietary IVIG, developed, manufactured, and released through the company’s integrated global network, reinforcing long‑term product consistency, quality, and supply reliability.

QIVIGY is being introduced in the U.S. through established specialty distributors and aligned GPO partnerships, reflecting Kedrion’s focus on broad commercial reach, dependable supply, and responsive service. These distribution and contracting pathways—including specialty distributors CuraScript SD; Cencora, Inc.; Cardinal Health, Inc.; McKesson Plasma and Biologics; and BioCare, Inc., as well as our exclusive GPO relationships across acute and non‑acute care settings, namely Premier, Inc. and Premier Innovatix—are designed to support efficient onboarding and adoption across specialty pharmacies, infusion centers, hospitals, and other sites of care, while enabling scalability as demand for IVIG therapies continues to grow.

“The U.S. introduction of QIVIGY reflects Kedrion’s continued evolution as a fully integrated biopharmaceutical company,” said Ugo Di Francesco, Chief Executive Officer of Kedrion. “Delivering a therapy conceived and advanced within Kedrion underscores the strength of our scientific capabilities and our commitment to bringing meaningful treatments to people who depend on immunoglobulin therapy.”

The availability of QIVIGY reflects more than a decade of scientific research, manufacturing investment, and cross‑functional collaboration, produced through Kedrion’s international manufacturing network. This approach reinforces the company’s long‑term strategy to expand access to high‑quality plasma‑derived therapies worldwide while ensuring rigorous quality standards and long‑term reliability for healthcare providers.

“QIVIGY’s nationwide availability is a defining moment for our company and for patients,” added Bob Rossilli, Chief Commercial Officer of Kedrion. “QIVIGY strengthens our U.S. immunoglobulin portfolio, it reinforces our commitment to providing customers with broad access, dependable supply, and the infrastructure needed to support consistent care delivery.”

IMPORTANT SAFETY INFORMATION

QIVIGY (immune globulin intravenous, human-kthm) is a 10% immune globulin (Ig) liquid indicated for the treatment of adults with primary humoral immunodeficiency. QIVIGY may cause:

Blood clots (thrombosis) may occur in people taking Ig intravenous (IGIV) products, including QIVIGY.

Renal dysfunction, acute renal failure, osmotic nephrosis may occur with IGIV products in predisposed patients. Such events require immediate medical intervention, if not recognized or managed appropriately, may result in persistent or significant disability or incapacity or lead to fatal outcome.

For patients at risk of thrombosis, renal dysfunction or failure, administer QIVIGY at the minimum dose available and the minimum infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

Do NOT use QIVIGY if you have had an anaphylactic or severe systemic reaction to the administration of human immune globulin and in IgA deficient patients with antibodies against IgA and history of hypersensitivity.

WARNINGS AND PRECAUTIONS

Severe hypersensitive reactions, including anaphylaxis, may occur. In case of hypersensitive, discontinue QIVIGY infusion and manage as appropriate.

Hyperproteinemia, hyperviscosity, and hyponatremia may occur in patients receiving IGIV treatment, including QIVIGY.

Aseptic meningitis syndrome may occur in patients receiving IGIV treatment, especially with high doses or rapid infusion.

Hemolysis can develop subsequent to IGIV treatment. Monitor patients for hemolysis.

Transfusion-related acute lung injury: Monitor patients for pulmonary adverse reactions.

Transmissible infectious agents: QIVIGY is made from human plasma and may carry a risk of transmitting infectious agents, eg, viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Interference with laboratory tests: After infusion of Ig, transitory rise of passively transferred antibodies may yield positive serological results, with potential for misleading interpretation.

ADVERSE REACTIONS

The most common adverse reactions occurring in > 5% of patients treated were headache, fatigue, infusion-related reaction, Coombs direct test positive, nausea, sinusitis, dizziness, and diarrhea.

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.

Please see full Prescribing Information for complete prescribing details, including Boxed Warning.

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 patient 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.

For information: Jessica Fetrow – US Communications

[email protected]

SOURCE Kedrion Biopharma

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