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).

武田宣布，美国食品药品监督管理局 (FDA) 已批准 GAMMAGARD LIQUID ERC [免疫球蛋白输注（人源）] 用于两岁及以上原发性免疫缺陷 (PI) 患者。

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..

原发性免疫缺陷是指由免疫系统部分功能失调或缺失引起的超过550种罕见的、通常为遗传性的疾病。这些疾病常常被漏诊，并可能导致反复感染和自身免疫并发症。在美国，每1200人中约有1人受原发性免疫缺陷影响。

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..

新批准的产品是唯一一种即用型液体免疫球蛋白（IG）疗法，其在10%溶液中免疫球蛋白A（IgA）含量低至小于或等于2 µg/mL。它通过消除重构需求简化了治疗过程，可以静脉注射或皮下注射。

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®.

这一批准使武田成为唯一一家提供具有如此低 IgA 水平的即用型液体 IG 疗法的制造商。预计该产品将于 2026 年在美国上市，随后于 2027 年在欧洲推出，其在欧洲获批的商品名为 DEQSIGA®。

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..

GAMMAGARD LIQUID ERC 与其现有的 GAMMAGARD LIQUID 产品共享生产工艺，但包括一个进一步降低 IgA 水平的特定工艺步骤。尽管该产品未被特别批准用于对 IgA 敏感的个体，但基于临床判断，它可能适用于此类患者。

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..

与此发展同步，武田公司也已确认计划停产GAMMAGARD S/D，这是一种以5%溶液中IgA水平低于1微克/毫升的冻干IG疗法。这款采用较旧生产工艺的产品将于2027年12月底停止生产。现有库存将继续供应，直至过期或耗尽。

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.

公司指出，GAMMAGARD S/D目前用于多种病症，包括原发性免疫缺陷病（PI）、慢性免疫性血小板减少性紫癜（ITP），以及预防川崎综合征中的冠状动脉瘤。

Takeda aims to give patients and healthcare providers adequate time to transition to alternative therapies.

武田旨在让患者和医疗保健提供者有足够的时间过渡到替代疗法。