Philadelphia, PA May 20 2024 -- GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved a 200 mg subcutaneous route of administration of Benlysta (belimumab), a B-lymphocyte stimulator (BLyS)-specific inhibiting monoclonal antibody, for patients five years of age and older with active systemic lupus erythematosus (SLE) who are receiving standard therapy.

2024年5月20日，宾夕法尼亚州费城——葛兰素史克股份有限公司（LSE/NYSE:GSK）今天宣布，美国食品和药物管理局（FDA）已批准一种200 mg皮下给药途径，用于接受标准治疗的5岁及以上活动性系统性红斑狼疮（SLE）患者的B淋巴细胞刺激物（BLyS）特异性抑制性单克隆抗体Benlysta（belimumab）。

This option provides pediatric patients the possibility to receive the treatment at home.Previously, children aged five years and older could only receive belimumab through an intravenous (IV) formulation, administered by healthcare professionals to patients as a weight-based dose of 10 mg/kg, via a one-hour infusion in a hospital or clinic setting every four weeks (following an initial loading phase given on days 0, 14 and 28).

这种选择为儿科患者提供了在家接受治疗的可能性。以前，五岁及以上的儿童只能通过静脉注射（IV）制剂接受belimumab，由医疗保健专业人员以10 mg/kg的体重剂量给患者服用，每四周在医院或诊所进行一小时输注（在第0,14和28天给予初始负荷阶段之后）。

Now, a child’s healthcare provider will determine if at-home administration is appropriate. If so, the healthcare provider will administer treatment or the healthcare provider will provide instructions to the patients’ caregiver that will allow them to administer the medicine at home via an autoinjector once per week for children who weigh 40 kg or more, or once every two weeks for children who weigh 15 kg to <40 kg.Lupus is a chronic, multi-organ (systemic) inflammatory disease caused when the immune system attacks its own tissues.

现在，儿童保健提供者将决定在家管理是否合适。如果是这样，医疗保健提供者将进行治疗，或者医疗保健提供者将向患者的护理人员提供指示，允许他们在家中通过自动注射器给体重40公斤或以上的儿童每周一次给药，或者体重15公斤至40公斤以下的儿童每两周一次给药。狼疮是一种慢性多器官（系统性）炎症性疾病，由免疫系统攻击自身组织引起。

There are between 5,000 and 10,000 children with SLE in the US. Children with lupus are more likely than adults to experience problems with vital organs – notably the kidney – and these organs accrue more damage in children.i,iiMary T. Crimmings, Interim CEO and Senior Vice President for Marketing and Communications, Lupus Foundation of America said: “Lupus tends to be more aggressive and affect children more severely than .

美国有5000至10000名儿童患有系统性红斑狼疮。患有狼疮的儿童比成年人更容易出现重要器官问题，尤其是肾脏，这些器官对儿童的损害更大。美国狼疮基金会临时首席执行官兼营销与传播高级副总裁i，iiMary T.Crimings表示：“狼疮往往比成人更具侵略性，对儿童的影响更为严重。