FDA Approves Gammagard Liquid ERC to Treat PI, Plans to Discontinue Gammagard SD in December 2027

The U.S. Food and Drug Administration (FDA) has approved GAMMAGARD LIQUID ERC [immune globulin infusion (human)] with less than or equal to 2 µg/mL IgA in a 10% solution, the only ready-to-use liquid immune globulin (IG) therapy with low immunoglobulin A (IgA) content, as replacement therapy for individuals 2 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 are providers by eliminating the need for reconstitution and can be administered intravenously or subcutaneously. Takeda anticipates commercialization of GAMMAGARD LIQUID ERC will begin in the U.S. in 2026.

“The approval of GAMMAGARD LIQUID ERC reinforces our commitment to supporting individualized treatment approaches for people with [PI], including a therapeutic option that has the lowest IgA content of any ready-to-use liquid [immune globulin] therapy, and can be administered intravenously or subcutaneously,” said Kristina Allikmets, senior vice president and head of research and 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 [immune globulin] 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.”

In parallel to this approval, and after thorough analysis, 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. As the only lyophilized (freeze-dried) preparation in Takeda’s IG portfolio, GAMMAGARD S/D uses a different, older manufacturing process. For GAMMAGARD S/D, this process is no longer able to reliably meet the future needs of the patient community. Therefore, Takeda has informed 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 expired.

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