TOKYO (dpa-AFX) - Takeda Pharmaceutical Company Limited (TAK) Monday said that the U.S. Food and Drug Administration (FDA) has approved GAMMAGARD LIQUID ERC, a ready-to-use liquid immunoglobulin (IG) therapy, as replacement therapy for people two years of age and older with primary immunodeficiency (PI).
In the U.S., the commercialization of GAMMAGARD LIQUID ERC is expected to begin in 2026, followed by the European Union in 2027, where GAMMAGARD LIQUID ERC is approved by the European Medicines Agency (EMA) as DEQSIGA.
'The approval of GAMMAGARD LIQUID ERC reinforces our commitment to supporting individualized treatment approaches for people with primary immunodeficiency, including a therapeutic option that has the lowest IgA content of any ready-to-use liquid immunoglobulin therapy, and can be administered intravenously or subcutaneously,' said Kristina Allikmets, senior vice president and head of Research & Development for Takeda's Plasma-Derived Therapies Business Unit.
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