近日，美国食品药品管理局（FDA）已同意快速审批GSK与美国人类基因组科学公司（HGS）合作推出的新药Benlysta (belimumab)，这是一种蛋白质疗法药，用于医治系统性红斑狼疮（SLE）。FDA对该药的审批工作有望于今年12月9日完成。
上述决定基于该药物的两项关键Ⅲ期临床试验数据，参加这两次试验的受试者达1684人，均为SLE患者。Benlysta是一种BLyS抑制剂类新型药物，也是在同类药当中首个完成Ⅲ期临床试验的产品。
试验结果显示，这种静脉注射制剂与目前的标准药联用之后，能够抑制SLE病情的发展，并且还能防止疾病的突然发作。
如果Benlysta最后能获准在美国上市，对当地SLE的治疗来说是一个进步，同时也可以为缺乏有效药物的SLE患者提供新的疗法。今年6月4日，GSK也向欧洲药品管理局递交了该药的销售申请。50多年来，还没有任何SLE新药通过批准。

Generic Name and Formulations:
Belimumab 120mg/vial, 400mg/vial; pwd for IV infusion after reconstitution and dilution.

Company:
Human Genome Sciences and GlaxoSmithKline

Indications for BENLYSTA:
Systemic lupus erythematosus, in adults with active, autoantibody-positive SLE on standard therapy.

Adult Dose for BENLYSTA:
Give by IV infusion over 1 hour; slower if infusion reaction occurs. 10mg/kg every 2 weeks for 3 doses, then 10mg/kg every 4 weeks. May premedicate for infusion/hypersensitivity reactions (eg, APAP, diphenhydramine).

Children's Dose for BENLYSTA:
Not recommended.

Pharmacological Class:
Human IgG1gamma monoclonal antibody.

Warnings/Precautions:
Severe active lupus nephritis or CNS lupus: not recommended. More deaths reported with Benlysta than placebo in clinical trials. Supervise infusion; have resuscitative equipment and trained personnel available in case of infusion/hypersensitivity reactions. Chronic infections: do not start therapy; if initiated, consider suspending if new infections develop and monitor closely. Monitor for malignancies, depression or other mood changes. Elderly. Black/African American. Pregnancy (Cat. C). Nursing mothers: not recommended.

Interactions:
Immunizations (may get suboptimal response); avoid live vaccines for 30 days prior to and during treatment. Concomitant other biologicals or IV cyclophosphamide: not recommended.

Adverse Reactions:
Infections (eg, URI, UTI, nasopharyngitis, sinusitis, bronchitis, influenza; may be serious/fatal), psychological effects (eg, depression, insomnia, anxiety, suicide), GI upset, fever, migraine, extremity pain, infusion and/or hypersensitivity reactions.

How Supplied:
Single-use vials (120mg in 5mL, 400mg in 20mL)—1