Takeda announced that the U.S. Food and Drug Administration (FDA) has approved GAMMAGARD LIQUID ERC, the first and only ready-to-use liquid immunoglobulin (IG) therapy with low immunoglobulin A (IgA) content (≤2 µg/mL) in a 10% solution, for the treatment of primary immunodeficiency (PI) in patients aged two years and older.
Unlike some IG therapies that require reconstitution, GAMMAGARD LIQUID ERC is a pre-prepared liquid solution that can be administered intravenously or subcutaneously, offering greater convenience for patients and healthcare providers.
“The approval of GAMMAGARD LIQUID ERC reinforces our commitment to individualized care for patients with primary immunodeficiency,” said Kristina Allikmets, senior vice president and head of R&D for Takeda’s Plasma-Derived Therapies Business Unit. “It combines the lowest IgA content among ready-to-use therapies with the flexibility of two routes of administration.”
The therapy is expected to launch in the U.S. in 2026, followed by a 2027 launch in the European Union, where it has already been approved under the brand name DEQSIGA.
In conjunction with this approval, Takeda also announced plans to discontinue GAMMAGARD S/D, its older, freeze-dried IG product with IgA levels under 1 µg/mL. Manufacturing of GAMMAGARD S/D will cease by the end of 2027 due to limitations in the aging production process. Takeda will maintain remaining supply until it is depleted or expires.
“We recognize the significance of this change for patients currently using GAMMAGARD S/D,” said Allikmets. “We are giving advanced notice to allow patients and healthcare providers ample time to transition to alternative therapies.”
With this move, Takeda aims to streamline its IG product portfolio while continuing to meet evolving patient needs with newer, more reliable formulations.