FORT LEE, N.J., August 18, 2026
Kedrion Biopharma announced an extension of its U.S. agreement with Grifols to continue marketing and selling GAMMAKED®, an intravenous immunoglobulin (IVIG) therapy used to treat patients with serious and chronic immune-mediated disorders. The agreement is intended to support long-term and reliable access to GAMMAKED across the United States and reinforces the companies’ longstanding relationship. GAMMAKED is indicated for primary humoral immunodeficiency (PI) in patients two years of age and older, idiopathic thrombocytopenic purpura (ITP) in adults and children, and chronic inflammatory demyelinating polyneuropathy (CIDP) in adults. The agreement strengthens Kedrion’s U.S. immunoglobulin portfolio while supporting continuity of treatment for patients who require ongoing therapy.
Agreement Strengthens Long-Term Patient Access
The extended relationship with Grifols is focused on maintaining broad and dependable access to GAMMAKED for patients living with chronic immune-mediated diseases. For individuals with conditions such as CIDP and primary immunodeficiency, treatment may require continued administration over an extended period, making reliable supply an important component of disease management. Kedrion said the agreement builds on more than a decade of successful sales and marketing activities for GAMMAKED in the United States. Under the extended arrangement, the company will continue using its established U.S. commercial infrastructure and market experience to market and sell the plasma-derived therapy nationwide. The agreement therefore provides a longer-term foundation for supporting healthcare providers and preserving treatment access for patients who depend on immunoglobulin therapy.
GAMMAKED Supports Multiple Immune-Mediated Conditions
GAMMAKED® is a plasma-derived immune globulin therapy containing human immunoglobulin and is used across several serious medical conditions. Its approved indications include primary humoral immunodeficiency, where it provides replacement immunoglobulin for eligible patients; ITP, a disorder involving low platelet levels; and CIDP, a progressive neurological disorder affecting peripheral nerves. The therapy forms part of Kedrion’s broader portfolio of immunoglobulin medicines and plasma-derived therapies for rare, serious and debilitating diseases. Kedrion collects and fractionates human blood plasma to produce therapies addressing immunodeficiencies, neurological disorders, coagulation conditions and other serious diseases. The company operates plasma collection centers in the United States and the Czech Republic and distributes a portfolio of products in more than 100 countries.
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Supply Reliability Remains Critical for IVIG Therapy
The extension also highlights the importance of reliable pharmaceutical supply networks for plasma-derived medicines. Kedrion emphasized that developing effective therapies is only part of supporting patients, with consistent delivery and dependable supply also essential for people receiving long-term treatment. GAMMAKED has been marketed by Kedrion in the United States for more than a decade, and the extended agreement is intended to maintain continuity while supporting the company’s ongoing commercial activities. As an IVIG product, GAMMAKED carries established safety considerations, including warnings related to thrombosis, renal dysfunction and acute renal failure, as well as potential hypersensitivity and other adverse reactions. The product is contraindicated in patients with certain severe hypersensitivity histories. These safety considerations reinforce the importance of appropriate clinical oversight when administering immunoglobulin therapy. The agreement between Kedrion and Grifols ultimately represents a pharmaceutical access and supply-continuity development that supports patients and healthcare providers while strengthening Kedrion’s position in the U.S. plasma-derived therapeutics market.
Source: Kedrion Biopharma press relese
