Takeda Gains FDA Approval For GAMMAGARD LIQUID ERC In Primary Immunodeficiency

Takeda has received U.S. FDA approval for GAMMAGARD LIQUID ERC, a 10% ready-to-use immune globulin (IG) therapy with low IgA content (≤2 µg/mL), indicated as replacement therapy for individuals aged two years and older with primary immunodeficiency (PI). Unlike lyophilized IG products, this formulation requires no reconstitution and can be administered intravenously or subcutaneously, potentially reducing the administration burden for patients and providers.

“We understand the impact that this news may have on patients who currently rely on GAMMAGARD S/D for their treatment. We are communicating this information now to allow time for patients to work closely with their health care teams to develop alternative treatment plans,” said Kristina Allikmets.

With this approval, Takeda remains the only company offering a 10% IG solution with such low IgA content. U.S. commercialization is expected in 2026, followed by EU launch in 2027 under the name DEQSIGA®. These timelines align with the scale-up period required for plasma-derived therapies.

“The approval of GAMMAGARD LIQUID ERC reinforces our commitment to supporting individualized treatment approaches for people with primary immunodeficiency, including a therapeutic option that has the lowest IgA content of any ready-to-use liquid immunoglobulin therapy, and can be administered intravenously or subcutaneously. 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,” said Kristina Allikmets, senior vice president and head of Research & Development for Takeda’s Plasma-Derived Therapies Business Unit. 

In team with the launch of GAMMAGARD LIQUID ERC, Takeda will phase out its older-generation IG therapy, GAMMAGARD S/D (IgA <1 µg/mL, 5% solution), which will be discontinued by the end of 2027. The manufacturing process for this freeze-dried formulation is no longer sustainable, and the product will remain available only while supplies last.