Kedrion Biopharma Announces the Extension of a U.S. Agreement with Grifols to Support Long-Term and Continued Access to GAMMAKED®

The agreement maintains key therapies within Kedrion's U.S. immunodeficiency and auto immune disorders portfolio while reinforcing broad, reliable access for people living with serious and chronic immune-mediated disorders

FORT LEE, N.J., Aug. 18, 2026 /PRNewswire/ -- Kedrion Biopharma, a global biopharmaceutical company specializing in therapies for rare and serious diseases, today announced an extension to their relationship with Grifols under which Kedrion sells GAMMAKED^® [Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified], an intravenous immunoglobulin (IVIG) therapy, in the United States to support patients living with serious and chronic conditions. The agreement builds on the longstanding relationship between the two companies with a shared mission to maintain broad and reliable access to GAMMAKED^® for patients living with primary humoral immunodeficiency (PI) in patients 2 years of age and older, idiopathic thrombocytopenic purpura (ITP) in adults and children, and chronic inflammatory demyelinating polyneuropathy (CIDP) in adults.

For patients with CIDP, a rare and progressive neurological disorder, and primary immunodeficiency, consistent access to therapy is essential. Because these conditions often require ongoing treatment, continuity of supply plays an important role in helping patients remain on therapy and manage disease progression over time.

"Our longstanding relationship with Grifols reflects a shared commitment to ensuring patients continue to have access to the therapies they depend on," said Ugo Di Francesco, Chief Executive Officer, Kedrion Biopharma. "This collaboration strengthens our ability to serve the U.S. market while reinforcing Kedrion's long-term commitment to investing in therapies, partnerships and capabilities that support patients living with serious and chronic conditions."

GAMMAKED^® is an established plasma-derived therapy in the United States and complements Kedrion's enduring expertise and existing portfolio of immunoglobulin medicines. Under the agreement, Kedrion will continue to market and sell GAMMAKED^® across the country through its established U.S. commercial infrastructure and market experience, reinforcing the company's ability to preserve treatment choice for physicians and provide reliable access for patients.

"Innovation doesn't end with developing effective therapies," said Bob Rossilli, Chief Commercial Officer, Kedrion Biopharma. "Delivering those therapies consistently and reliably is equally important. Our focus is on having a dependable supply network that healthcare providers can count on to keep a growing patient population on therapy without interruption."

The agreement further builds on more than a decade of successful sales and marketing for GAMMAKED^® by Kedrion and reinforces the commitment to maintain and grow reliable access, providing a long-term stable foundation for continued support of patients and healthcare providers.

GAMMAKED^® is a registered trademark of Kedrion Biopharma Inc.

About Kedrion 

Kedrion Biopharma collects and fractionates blood plasma to produce and distribute plasma‑derived therapies for rare, ultra‑rare, and debilitating conditions, including coagulation and neurological disorders, immunodeficiencies, and Rh sensitization. We employ approximately 5,400 people worldwide and operate plasma collection centers in the United States and the Czech Republic. With a portfolio of 39 products distributed in over 100 countries, Kedrion is the world's fifth‑largest player in plasma‑derived products.

We are committed to creating a world where science and care know no bounds, working in partnership with the medical‑scientific community, institutions, patient organizations, and research bodies to foster innovation and improve care. Every connection we make impacts someone, somewhere. 

www.kedrion.com 

Contact
Jay Williams, US Communications
[email protected] 

About GAMMAKED^®

INDICATIONS AND USAGE

GAMMAKED [Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified] is an immune globulin injection that is indicated to treat primary humoral immunodeficiency (PI) in patients 2 years of age and older, idiopathic thrombocytopenic purpura (ITP) in adults and children, and chronic inflammatory demyelinating polyneuropathy (CIDP) in adults.

IMPORTANT SAFETY INFORMATION

Boxed Warning: Thrombosis, Renal Dysfunction and Acute Renal Failure

Thrombosis may occur with immune globulin products, including GAMMAKED. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors.

For patients at risk of thrombosis, administer GAMMAKED 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.

Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with immune globulin intravenous (IGIV) products in predisposed patients. Patients predisposed to renal dysfunction include those with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs.

Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. GAMMAKED does not contain sucrose.

For patients at risk of renal dysfunction or failure, administer GAMMAKED at the minimum concentration available and the minimum infusion rate practicable.

CONTRAINDICATIONS

GAMMAKED is contraindicated in patients who have had an anaphylactic or severe systemic reaction to human immunoglobulin. It is also contraindicated in IgA deficient patients with antibodies against IgA and history of hypersensitivity. Have epinephrine available immediately to treat any acute severe hypersensitivity reactions.

WARNINGS AND PRECAUTIONS

Hypersensitivity: Severe hypersensitivity reactions may occur with IGIV products, including GAMMAKED. In case of hypersensitivity, discontinue GAMMAKED infusion immediately and institute appropriate treatment. GAMMAKED contains trace amounts of IgA (average 46 micrograms/mL). Patients with known antibodies to IgA may have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions. It is contraindicated in IgA deficient patients with antibodies against IgA and history of hypersensitivity reaction.

Renal Failure: Acute renal dysfunction/failure, acute tubular necrosis, proximal tubular nephropathy, osmotic nephrosis and death may occur upon use of IGIV products, especially those containing sucrose. GAMMAKED does not contain sucrose. Ensure that patients are not volume depleted prior to the initiation of the infusion of GAMMAKED. Periodic monitoring of renal function and urine output is particularly important in patients judged to have a potential increased risk for developing acute renal failure. Assess renal function, including measurement of blood urea nitrogen (BUN)/serum creatinine, prior to the initial infusion of GAMMAKED and again at appropriate intervals thereafter. If renal function deteriorates, consider discontinuation of GAMMAKED. For patients judged to be at risk for developing renal dysfunction, including patients with any degree of pre-existing renal insufficiency or risk factors for renal insufficiency, administer GAMMAKED at the minimum infusion rate practicable [less than 8 mg/kg/min (0.08 mL/kg/min)].

Hyperproteinemia, Increased Serum Viscosity, and Hyponatremia: Hyperproteinemia, increased serum viscosity, and hyponatremia may occur in patients receiving IGIV therapy, including GAMMAKED. It is clinically critical to distinguish true hyponatremia from a pseudohyponatremia that is associated with concomitant decreased calculated serum osmolality or elevated osmolar gap, because treatment aimed at decreasing serum free water in patients with pseudohyponatremia may lead to volume depletion, a further increase in serum viscosity and a possible predisposition to thrombosis.

Aseptic Meningitis Syndrome (AMS): Aseptic Meningitis Syndrome (AMS) may occur infrequently, especially with high doses or rapid infusion.

Hemolysis: Hemolysis, either intravascular or due to enhanced red blood cell (RBC) sequestration, can develop subsequent to GAMMAKED treatment. Risk factors include high doses and non-O blood group. Closely monitor patients for hemolysis and hemolytic anemia, especially in patients with pre-existing anemia and/or cardiovascular or pulmonary compromise.

Transfusion-related Acute Lung Injury (TRALI): Noncardiogenic pulmonary edema may occur in patients following treatment with IGIV products, including GAMMAKED. Monitor patients for pulmonary adverse reactions (transfusion-related acute lung injury [TRALI]).

Volume Overload: The high dose regimen (1g/kg x 1-2 days) is not recommended for individuals with expanded fluid volumes or where fluid volume may be a concern.

Transmission of Infectious Agents: GAMMAKED is made from human plasma. Because this product is made from human plasma, it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Hematoma Formation: GAMMAKED is not approved for subcutaneous use in patients with ITP. Due to the potential risk of hematoma formation, GAMMAKED should not be administered subcutaneously in patients with ITP.

Interference with Laboratory Tests: After infusion of IgG, the transitory rise of the various passively transferred antibodies in the patient's blood may yield positive serological testing results, with the potential for misleading interpretation.

ADVERSE REACTIONS

In clinical studies, the most common adverse reactions with GAMMAKED (≥5% of subjects) were: (in PI intravenous) cough increased, rhinitis, pharyngitis, headache, asthma, nausea, fever, diarrhea, and sinusitis; (in PI subcutaneous) local infusion site reactions, fatigue, headache, upper respiratory tract infection, arthralgia, diarrhea, nausea, sinusitis, bronchitis, depression, allergic dermatitis, erythema, migraine, myalgia, viral infection, and pyrexia; (in ITP) headache, ecchymosis, vomiting, fever, nausea, rash, abdominal pain, back pain, and dyspepsia; (in CIDP) headache, pyrexia, hypertension, chills, rash, nausea, arthralgia, and asthenia.

Please click here for the Full Prescribing Information for complete prescribing details including Boxed Warning, contraindications and dosing and administration information.

SOURCE Kedrion Biopharma