Takeda Gains U.S. FDA Approval for GAMMAGARD LIQUID ERC, a Ready-to-Use Low-IgA Immunoglobulin Therapy
Tuesday, July 01, 2025
Takeda has received approval from the U.S. Food and Drug Administration (FDA) for GAMMAGARD LIQUID ERC, an immune globulin infusion (human) with low immunoglobulin A (IgA) content. The approved formulation, with ≤2 µg/mL IgA in a 10% solution, is the first ready-to-use liquid immunoglobulin therapy of its kind for individuals aged two years and above with primary immunodeficiency (PI).
GAMMAGARD LIQUID ERC is designed to reduce treatment burden by offering a liquid formulation that does not require reconstitution before use. It can be administered either intravenously or subcutaneously, providing greater flexibility for patients and healthcare providers.
The product is produced using the same advanced manufacturing process as Takeda’s existing liquid immunoglobulin therapies. The company plans to launch GAMMAGARD LIQUID ERC in the U.S. market in 2026, followed by a rollout in the European Union in 2027 under the name DEQSIGA®, as approved by the European Medicines Agency (EMA). The delay allows time to build manufacturing capacity and ensure a reliable supply.
Alongside this development, Takeda has announced the planned discontinuation of GAMMAGARD S/D, a freeze-dried immunoglobulin therapy with IgA levels below 1 µg/mL in a 5% solution. This older product relies on a legacy manufacturing process that no longer meets long-term supply demands. Production of GAMMAGARD S/D will cease by the end of December 2027, although existing supplies will remain available until depleted or expired.
Takeda has begun informing healthcare authorities and patients in advance to support a smooth transition and ensure that treatment plans can be adjusted accordingly.
Source: businesswire.com
