Takeda announced today that the U.S. Food and Drug Administration (FDA) has approved GAMMAGARD LIQUID ERC [immune globulin infusion (human)], a 10% ready-to-use liquid immunoglobulin (IG) therapy with low IgA content (≤2 µg/mL). It is now approved as replacement therapy for individuals aged two years and older with primary immunodeficiency (PI).
GAMMAGARD LIQUID ERC is the only available ready-to-use liquid IG therapy in the U.S. with this low level of IgA, which is particularly important for patients who are sensitive or allergic to IgA. The product can be administered both intravenously (IV) or subcutaneously (SC), offering flexibility and convenience for healthcare providers and patients. Its ready-to-use liquid formulation eliminates the need for reconstitution, simplifying the treatment process.
“The approval of GAMMAGARD LIQUID ERC reinforces Takeda’s commitment to personalized treatment for people with primary immunodeficiency,” said Kristina Allikmets, Senior Vice President and Head of R&D at Takeda’s Plasma-Derived Therapies Business Unit. “With the lowest IgA content among ready-to-use liquid IG therapies, and dual administration routes, this therapy supports diverse patient needs.”
The newly approved formulation is manufactured using the same advanced process as Takeda’s other liquid immunoglobulin therapies. This approach aligns with the company’s long-term strategy to ensure reliable supply while expanding options within its IG portfolio.
With the U.S. FDA approval secured, Takeda plans to launch GAMMAGARD LIQUID ERC commercially in 2026, followed by a 2027 launch in the European Union, where it is already approved under the name DEQSIGA® by the European Medicines Agency (EMA). The timeline allows for a structured scale-up of manufacturing and distribution, which is crucial in the context of plasma-derived therapies.
As part of its evolving product strategy, Takeda also announced plans to discontinue GAMMAGARD S/D, its older, freeze-dried (lyophilized) IG therapy that contains less than 1 µg/mL IgA in a 5% solution. The decision follows an in-depth evaluation of the legacy manufacturing process, which is no longer sustainable for meeting future global patient needs. Production of GAMMAGARD S/D will cease at the end of December 2027, with existing inventory maintained until it is either exhausted or expired.
“We understand this may impact patients currently on GAMMAGARD S/D,” said Allikmets. “That’s why we’re sharing this update early—to give patients and healthcare providers sufficient time to explore alternative treatment options.”
Takeda remains committed to supporting the PI community by offering innovative and adaptable immune globulin therapies that meet modern clinical standards.