Takeda's U.S. FDA approval of GAMMAGARD LIQUID ERC marks a significant advancement for individuals living with primary immunodeficiency (PI), a group of over 550 rare, chronic disorders where the immune system doesn't function correctly, making affected individuals more susceptible to frequent, severe, or unusual infections. This new immune globulin (IG) therapy stands out as the only ready-to-use liquid formulation with a remarkably low immunoglobulin A (IgA) content of ≤ 2 µg/mL in a 10% solution, offering a critical treatment option for patients aged two and older. The "ready-to-use" aspect is a key benefit, simplifying administration for both patients and healthcare providers by eliminating the need for reconstitution, and it can be delivered either intravenously (into a vein) or subcutaneously (under the skin), providing flexibility in treatment.

This approval underscores Takeda's dedication to personalized PI care, particularly for those who may benefit from a low IgA option, even though the product is not specifically indicated for IgA sensitivity. The company employs the same advanced manufacturing process as its other liquid IG formulations, ensuring a consistent and reliable supply. While U.S. commercialization of GAMMAGARD LIQUID ERC is anticipated in 2026, it's already approved in the European Union as DEQSIGA®, with a projected launch there in 2027.

In a strategic move to streamline its portfolio and prioritize patient needs, Takeda has also announced the discontinuation of GAMMAGARD S/D, its first-generation, freeze-dried low-IgA product, by the end of December 2027. This decision was made because the older manufacturing process for GAMMAGARD S/D can no longer reliably meet future demand. Takeda is actively communicating this transition to healthcare authorities and patients, aiming to provide ample time for individuals currently using GAMMAGARD S/D to work with their healthcare teams and establish alternative treatment plans, with existing inventory maintained until depleted or expired. This transition reflects Takeda's forward-looking approach to ensure sustainable and accessible therapeutic options for the PI community.