Takeda Reports US FDA Approval of GAMMAGARD LIQUID ERC for Primary Immunodeficiency
- The US FDA has approved GAMMAGARD LIQUID ERC [immune globulin infusion (human)] for treating primary immunodeficiency (PI) pts (age≥2); commercialization will be anticipated in 2026 and in the EU in 2027, where it’s approved as DEQSIGA by the EMA
- GAMMAGARD LIQUID ERC is a 10% ready-to-use IG therapy with ≤2 µg/mL IgA, for IV or SC use approved in the U.S. for PI pts (age≥2)
- In parallel with this approval, due to outdated manufacturing, Takeda will discontinue GAMMAGARD S/D, its first-generation low-IgA IG product, by the end of 2027. Inventory will be available until depleted or expires
Ref: Takeda | Image: Takeda | Press Release
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