Takeda has announced that the U.S. Food and Drug Administration (FDA) has approved GAMMAGARD LIQUID ERC [immune globulin infusion (human)] for use in patients aged two years and above with primary immunodeficiency (PI).
• Primary immunodeficiency refers to a group of more than 550 rare, often inherited conditions caused by dysfunction or absence of part of the immune system.
• These disorders are frequently underdiagnosed and can lead to recurrent infections and autoimmune complications. PI affects approximately 1 in 1,200 individuals in the United States.
• The newly approved product is the only ready-to-use liquid immunoglobulin (IG) therapy with a low immunoglobulin A (IgA) content of less than or equal to 2 µg/mL in a 10% solution.
• It is designed to simplify treatment by eliminating the need for reconstitution and can be administered either intravenously or subcutaneously.
Takeda: A gamechanger
• This approval positions Takeda as the only manufacturer offering a ready-to-use liquid IG therapy with such a low IgA level.
• Commercial availability in the United States is expected in 2026, followed by a European launch in 2027, where the product is approved under the name DEQSIGA®.
Takeda Introduces GAMMAGARD LIQUID ERC with Enhanced IgA Reduction for Select Patients
• GAMMAGARD LIQUID ERC shares its manufacturing process with Takeda’s existing GAMMAGARD LIQUID product, but includes a specific process step that reduces IgA levels further.
• Although not specifically approved for individuals with IgA sensitivity, the product may be suitable for such patients based on clinical judgement.
In conjunction with this development, Takeda has also confirmed plans to discontinue GAMMAGARD S/D, a lyophilised IG therapy with IgA levels under 1 µg/mL in a 5% solution. This product, which uses an older manufacturing process, will cease production by the end of December 2027. Existing supplies will remain available until they expire or are depleted.
Current indication- The company noted that GAMMAGARD S/D is currently used for various conditions, including PI, chronic immune thrombocytopenic purpura (ITP), and prevention of coronary artery aneurysms in Kawasaki syndrome.
Takeda aims to give patients and healthcare providers adequate time to transition to alternative therapies.