Japan-based Takeda Pharmaceutical (TYO: 4502, NYSE: TAK) announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its Gammagard Liquid Erc [immune globulin infusion (human)]. The product is approved as replacement therapy for individuals aged two years and older with primary immunodeficiency (PI).
Product Details
Gammagard Liquid Erc is a ready-to-use immunoglobulin infusion that does not require reconstitution before clinical administration. It can be delivered via intravenous (IV) or subcutaneous (SC) routes, potentially reducing the treatment burden for patients. With an IgA content of ≤2 µg/mL in its 10% solution, it is currently the only ready-to-use immunoglobulin product with low IgA levels available in the market.
Commercial Launch
The product is expected to be commercially launched in the US in 2026. Following this, a European rollout is planned for 2027, where it has already been approved under the brand name Deqsiga.-Fineline Info & Tech
