Takeda's GAMMAGARD LIQUID ERC Approved by FDA as Low IgA Immunoglobulin Therapy

OSAKA, Japan & CAMBRIDGE, Mass.—Takeda has announced the approval of its new immunoglobulin therapy, GAMMAGARD LIQUID ERC, by the U.S. Food and Drug Administration (FDA). This innovative product, with an IgA content of less than or equal to 2 µg/mL in a 10% solution, is designed for individuals aged two and above suffering from primary immunodeficiency (PI). As the only ready-to-use liquid immunoglobulin therapy with low IgA content, it aims to alleviate the administration burden for both patients and healthcare providers by eliminating the need for reconstitution and offering flexibility in delivery, either intravenously or subcutaneously.

Kristina Allikmets, Senior Vice President and head of Research & Development for Takeda's Plasma-Derived Therapies Business Unit, emphasized that the approval underscores Takeda's dedication to providing tailored treatment options for those with PI. GAMMAGARD LIQUID ERC, she noted, is manufactured using the same advanced processes as other Takeda liquid immunoglobulin products, aligning with the company's strategy to ensure reliable supply and diverse options catering to various patient needs.

Takeda remains the sole manufacturer offering immunoglobulin therapy with such low IgA content in a 10% solution. The company anticipates launching GAMMAGARD LIQUID ERC commercially in the U.S. in 2026, with subsequent introduction in the European Union in 2027, where it is recognized as DEQSIGA by the European Medicines Agency (EMA). The timeline for commercialization is aligned with the necessary period to scale up manufacturing and supply chains for therapies derived from plasma.

In light of these developments, Takeda has decided, after extensive review, to discontinue its earlier product, GAMMAGARD S/D, which has less than 1 µg/mL IgA in a 5% solution. As the only freeze-dried preparation in Takeda's portfolio, GAMMAGARD S/D utilizes an aging manufacturing process that no longer meets the evolving needs of patients reliably. Takeda has communicated this discontinuation plan to the FDA and other health authorities, indicating that production will cease by the close of December 2027. The company has assured that existing inventories will be maintained until they are exhausted or expire.

“We recognize the potential impact on patients who currently depend on GAMMAGARD S/D for their treatment,” Allikmets stated. Takeda is sharing this information proactively to allow sufficient time for patients to collaborate with healthcare teams on alternative treatment strategies.

About GAMMAGARD LIQUID ERC

GAMMAGARD LIQUID ERC represents a breakthrough in immunoglobulin therapy, offering a liquid solution with IgA levels of 2 µg/mL or lower for intravenous or subcutaneous administration. It is approved in the U.S. for replacing immunoglobulin in individuals aged two and older with primary immunodeficiency (PI). The enhanced removal capability (ERC) in its production process—which it shares with GAMMAGARD LIQUID—results in efficient IgA reduction. While not expressly indicated for IgA sensitivity in primary immunodeficiency patients, it might be suitable for those based on medical evaluation. However, it should not be used by individuals with severe hypersensitivity or anaphylactic reactions to the product.

About GAMMAGARD S/D

GAMMAGARD S/D, a lyophilized immunoglobulin option with IgA content below 1 µg/mL, is approved for intravenous administration. It serves multiple purposes beyond PI treatment, including preventing bacterial infections in specific immune conditions and managing adult immune thrombocytopenic purpura. Additionally, it is used to treat Kawasaki syndrome in children, aiming to prevent coronary artery complications.

About Primary Immunodeficiency (PI)

Primary immunodeficiency includes over 550 rare and persistent disorders where the immune system is either incomplete or malfunctioning. These genetic conditions, often inherited, can result in frequent infections and atypical autoimmunity, leading to prolonged diagnostic challenges. In the U.S., PI affects roughly one in 1,200 individuals, impacting their quality of life significantly.

Through the approval and upcoming commercialization of GAMMAGARD LIQUID ERC, Takeda reaffirms its commitment to innovation in immunotherapy, providing new hope to those impacted by primary immunodeficiency.