YIMMUGO® Now Available in the U.S.: Kedrion Biopharma Commercializes a New Ig Therapy for PI

FORT LEE, N.J., Oct. 9, 2025 /PRNewswire/ -- Kedrion Biopharma is proud to announce the U.S. availability of YIMMUGO (Immune Globulin Intravenous, Human-dira, 10%), marking a major milestone in the company's expanding U.S. product portfolio and underscoring its commitment to broadening access to innovative therapies for patients with primary immunodeficiency (PI).

Introduced in Europe in 2022 and approved by the U.S. Food and Drug Administration (FDA) on June 13, 2024, YIMMUGO is a modern, highly purified 10% intravenous immunoglobulin (IVIG) indicated for the treatment of PI in patients aged 2 years and older. Developed by Biotest AG, a part of the Grifols group, YIMMUGO represents an innovation in immunoglobulin (Ig) therapy.  In 2024, Biotest AG granted Kedrion Biopharma exclusive rights to commercialize YIMMUGO in the United States.

PI refers to a group of more than 550 rare, chronic disorders in which the body's immune system is unable to function properly. Because the immune system serves as the body's defense against infections, individuals with PI are more vulnerable to frequent infections, autoimmune complications, and other serious health issues.

It is estimated that approximately 500,000 people in the United States and around 6 million globally are currently living with PI. However, these figures are likely underrepresented, as many individuals remain underdiagnosed or misdiagnosed, making it difficult to capture the true scope of the condition.

In a large market where demand for treatment options is rising, driven by the increasing prevalence of PI and the urgent need to address unmet patient needs, YIMMUGO enters as a meaningful new option. "We are implementing a bold and patient-centric strategy to expand and differentiate our Ig portfolio. Our experience, agility, and unwavering dedication to patients and health care practitioners in the IVIG sector position us to make a meaningful impact on the market," said Bob Rossilli, Chief Commercial Officer and U.S. General Manager at Kedrion Biopharma.

YIMMUGO is now available in the United States through a limited distribution network that includes multiple specialty pharmacies. For a complete list, please visit the website. CuraScript SD by Evernorth serves as YIMMUGO's exclusive commercial distribution partner, ensuring streamlined access for patients and providers.

About YIMMUGO

YIMMUGO is a polyvalent immunoglobulin G preparation from human blood plasma for intravenous immunoglobulin (IVIg) administration for the treatment of primary humoral deficiency (PID) in patients 2 years of age or older. YIMMUGO is the first approved product from the new Biotest Next Level production facility.

IMPORTANT SAFETY INFORMATION
BOXED WARNING: THROMBOSIS, RENAL DYSFUNCTION and ACUTE RENAL FAILURE
See full Prescribing Information for YIMMUGO.

• Thrombosis may occur with immune globulin intravenous (IGIV) products, including YIMMUGO. (5.3)
• Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with the administration of IGIV products in predisposed patients. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. YIMMUGO does not contain sucrose. (5.4)
• For patients at risk of thrombosis, renal dysfunction or renal failure, administer YIMMUGO at the minimum dose and 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. (2.1, 2.3, 5.3)

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.

Media Contact: Jennifer Donegan – US Communications Lead
[email protected]

SOURCE Kedrion Biopharma