CAMBRIDGE, Mass. — Takeda has announced the U.S. availability of GAMMAGARD LIQUID ERC, a ready-to-use liquid immunoglobulin therapy with low immunoglobulin A content, approved for people aged two and older with primary immunodeficiency.
The product, available by prescription, is formulated as a 10 percent immune globulin infusion with IgA levels less than or equal to 2 micrograms per milliliter. It is approved for use as replacement therapy and can be administered either intravenously or subcutaneously. Unlike some immunoglobulin therapies, GAMMAGARD LIQUID ERC does not require reconstitution prior to administration.
Takeda said the therapy was developed to address the needs of patients who require immunoglobulin replacement options with low IgA content. GAMMAGARD LIQUID ERC uses the same manufacturing platform as other liquid immunoglobulin products in the company’s portfolio and incorporates an Enhanced Removal Capability process designed to reduce IgA levels.
“As the latest addition to our broad IG portfolio, GAMMAGARD LIQUID ERC underscores our ongoing dedication to providing differentiated therapeutic options to meet the varied needs of people with primary immunodeficiency, including those who require an option with low IgA content,” said Uthra Sundaram, senior vice president and head of Takeda’s U.S. Plasma-Derived Therapies Business Unit.
The product is supplied in two vial sizes, 5 grams per 50 milliliters and 10 grams per 100 milliliters. It can be stored at room temperature for up to 24 months or refrigerated for up to 36 months, according to the company.
Takeda said it remains the only manufacturer offering an immunoglobulin therapy with IgA content at or below 2 micrograms per milliliter in a 10 percent solution. Its existing immunoglobulin portfolio also includes GAMMAGARD S/D, a freeze-dried formulation with IgA levels below 1 microgram per milliliter in a 5 percent solution, which requires reconstitution before use.
GAMMAGARD LIQUID ERC is indicated in the U.S. for replacement therapy in patients with primary immunodeficiency aged two years and older. While it is not specifically indicated for IgA sensitivity, Takeda noted that its use in such patients may be considered based on a physician’s clinical judgment.
The product is contraindicated in patients with a history of severe systemic hypersensitivity or anaphylactic reactions to immune globulin products. Takeda also cautioned that, despite the low IgA content, there remains a risk of severe hypersensitivity reactions, including anaphylaxis.
