CAMBRIDGE, Mass.– Takeda Pharmaceutical Company announced Monday that the U.S. Food and Drug Administration has approved GAMMAGARD LIQUID ERC, the first and only ready-to-use liquid immunoglobulin therapy with ultra-low levels of immunoglobulin A (IgA), for patients with primary immunodeficiency (PI) aged two and older.
The newly approved treatment contains no more than 2 µg/mL of IgA in a 10% solution and is cleared for both intravenous and subcutaneous administration. Takeda expects to launch the therapy in the U.S. market in 2026, with a European rollout under the name DEQSIGA® anticipated in 2027.
“This approval reinforces our commitment to providing individualized treatment options for people with primary immunodeficiency,” said Kristina Allikmets, head of R&D for Takeda’s Plasma-Derived Therapies unit. “GAMMAGARD LIQUID ERC offers patients and providers a ready-to-use formulation with the lowest IgA content in its class, streamlining administration and improving convenience.”
Unlike older lyophilized formulations that require reconstitution before infusion, GAMMAGARD LIQUID ERC is designed for ease of use, utilizing the same modern manufacturing process behind Takeda’s broader liquid immunoglobulin portfolio. Its low IgA profile makes it a suitable option for patients with known sensitivity to IgA, who may be at increased risk of allergic reactions.
Alongside the new approval, Takeda also announced it will phase out GAMMAGARD S/D, the company’s first-generation low-IgA immunoglobulin product, by the end of 2027. GAMMAGARD S/D is a freeze-dried formulation with IgA levels below 1 µg/mL in a 5% solution, but uses an older production process that Takeda says is no longer viable for long-term supply demands.
“We understand this transition may affect current patients using GAMMAGARD S/D,” Allikmets said. “We are sharing this timeline now to ensure that patients and healthcare providers have adequate time to develop alternative treatment plans.”
Takeda plans to maintain existing inventories of GAMMAGARD S/D until they expire or are fully depleted after manufacturing ceases in December 2027.
