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FDA Approves Takeda’s Gammagard Liquid ERC

It is the only ready-to-use liquid immunoglobulin therapy with (IgA) content and is set for commercialization in 2026.

By: Rachel Klemovitch

Assistant Editor

Takeda received U.S. Food and Drug Administration (FDA) approval for Gammagard Liquid ERC [immune globulin infusion (human)]. The therapy has less than or equal to 2 µg/mL IgA in a 10% solution and is the only ready-to-use liquid immunoglobulin (IG) therapy with low immunoglobulin A (IgA) content. Gammagard Liquid ERC is designed as replacement therapy for people two years of age and older with primary immunodeficiency (PI). 

As a ready-to-use liquid, Gammagard Liquid ERC may help ease the administration burden for patients and their health care providers by eliminating the need for reconstitution and can be administered intravenously or subcutaneously.

It is anticipated that commercialization of Gammagard Liquid ERC will begin in the U.S. in 2026, followed by the European Union in 2027, where Gammagard Liquid ERC is approved by the European Medicines Agency (EMA) as Deqsiga. 

Additionally, Takeda has decided to discontinue Gammagard S/D [Immune Globulin Intravenous (Human)] IgA less than 1 µg/mL in a 5% solution, the company’s first-generation low IgA product.

Takeda has informed the FDA and other health authorities that manufacturing of GAMMAGARD S/D will be discontinued at the end of December 2027. Beyond that date, Takeda intends to maintain Gammagard S/D inventory until it is depleted or expires.

Kristina Allikmets, senior vice president and head of Research & Development for Takeda’s Plasma-Derived Therapies Business Unit. “Gammagard Liquid ERC uses the same state-of-the-art manufacturing process as our other ready-to-use liquid immunoglobulin formulations and is aligned with our forward-looking strategy to prioritize reliable supply while offering a broad range of immunoglobulin therapies to address varied patient needs.”

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