The FDA has approved GAMMAGARD LIQUID ERC with IgA content less than or equal to 2 µg/mL in a 10% solution as replacement therapy for individuals aged 2 years and older with primary immunodeficiency.
With this approval, Takeda remains the only manufacturer of immunoglobulin therapy with IgA content less than or equal to 2 µg/mL in a 10% ready-to-use liquid formulation. GAMMAGARD LIQUID ERC [immune globulin infusion (human)] can be administered intravenously or subcutaneously, eliminating the need for reconstitution required by lyophilized immunoglobulin products.
According to Takeda, the new product shares a manufacturing process with GAMMAGARD LIQUID, with modifications to a single process step to enhance immunoglobulin A reduction. “GAMMAGARD LIQUID ERC uses the same state-of-the-art manufacturing process as our other ready-to-use liquid immunoglobulin formulations,” stated Kristina Allikmets, senior vice president and head of Research & Development for Takeda’s Plasma-Derived Therapies Business Unit.
In parallel with the approval, Takeda announced the planned discontinuation of GAMMAGARD S/D [immune globulin intravenous (human)], a 5% lyophilized formulation with IgA content less than 1 µg/mL, by the end of December 2027. The company stated that the older manufacturing process used for this product “is no longer able to reliably meet the future needs of the patient community.” Takeda intends to maintain inventory of GAMMAGARD S/D until supply is depleted or expired.
Primary immunodeficiency comprises more than 550 rare, chronic disorders caused by genetic mutations that result in missing or dysfunctional components of the immune system. Symptoms may include frequent infections and atypical autoimmunity, often resulting in prolonged misdiagnosis. In the United States, primary immunodeficiency affects approximately 1 in 1,200 individuals.
The safety profile of GAMMAGARD LIQUID ERC is supported by two clinical studies conducted using GAMMAGARD LIQUID. No clinical studies have been conducted using GAMMAGARD LIQUID ERC specifically. For intravenous administration, the most common adverse reactions observed in ≥5% of patients included headache, fatigue, pyrexia, chills, nausea, pain in extremity, diarrhea, migraine, vomiting, dizziness, urticaria, cough, asthma, oropharyngeal pain, infusion site extravasation, arthralgia, rash, myalgia, pruritus, and cardiac murmur.
For subcutaneous administration, the most common adverse reactions included infusion site events, headache, pyrexia, fatigue, increased heart rate, upper abdominal pain, vomiting, arthralgia, nausea, asthma, increased systolic blood pressure, diarrhea, ear pain, aphthous ulcer, migraine, oropharyngeal pain, and pain in extremity.
GAMMAGARD LIQUID ERC carries boxed warnings for thrombosis and renal dysfunction. It is contraindicated in individuals with a history of severe systemic hypersensitivity or anaphylactic reactions to the product. Despite its low IgA content, the risk of anaphylaxis remains.
Commercial launch in the United States is expected in 2026, followed by European Union availability in 2027, where the product is approved as DEQSIGA®. The timeline reflects manufacturing scale-up typical for plasma-derived therapies.