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2014年10月12日讯 /生物谷BIOON/ --导读：Humira（修美乐）是全球最畅销的药物之一，该药2013年全球销售额高达106亿美元，位列2013年最畅销药物排行榜榜单之首，2014第二季度销售额高达32.9亿美元，该药是艾伯维（AbbVie）的旗舰产品，也是全球首个获批的抗TNF-α单抗药物，适应症已达8个之多。9月下旬，FDA才批准了Humira第8个适应症——儿科克罗恩病，近日，Humira监管方面又传来喜讯，FDA已批准扩大Humira儿科多关节型幼年特发性关节炎（JIA）适应症范围，用于2-4岁多关节型JIA儿科患者的治疗。此前，FDA已授予Humira治疗2-4岁多关节型JIA的孤儿药地位。
艾伯维（AbbVie）近日宣布，FDA已批准扩大Humira儿科多关节型幼年特发性关节炎（JIA）适应症的年龄范围，用于2岁及以上中度至重度活动性多关节幼年特发性关节炎（JIA）儿科患者的治疗，以改善患者的症状和体征。此前，FDA已于2008年批准Humira用于4岁及以上多关节型JIA患者的治疗。此次批准，将使Humira成为2-4岁多关节型JIA儿科患者的重要治疗选择。
幼年特发性关节炎（JIA）是一种持续性或反复发作的关节的炎症，它与类风湿性关节炎相似，但发病时间在16岁或之前。该病是16岁以下儿童常见的结缔组织病，以慢性关节炎为主要特征，典型的关节炎的表现是疼痛、肿胀和活动受限。除关节炎症和畸形外，常有皮疹、肝脾及淋巴结肿大、胸膜炎和心包炎等全身症状和内脏损害。多数预后良好，少数可导致关节永久损害和慢性虹膜睫状体炎，是小儿致残的主要原因。
多关节型JIA约占所有JIA病例的25%，也是7种JIA类型之一，累及5个或更多关节。症状包括疼痛、肿胀、压痛关节、晨僵、跛行、手足活动减少等。及早诊断及恰当治疗，在这种慢性疾病的临床管理中至关重要。
在欧盟，Humira于2008年批准用于4岁-17岁儿童和青少年多关节型幼年特发性关节炎（JIA）患者的治疗。在2013年，EMA批准扩大Humira用于多关节型JIA适应症的年龄范围，扩大至2-17岁多关节型JIA患者群体。
在美国，Humira获批的8个适应症包括：中度至重度类风湿关节炎，中度至重度慢性斑块型银屑病，中度至重度克罗恩病；中度至重度溃疡性结肠炎，强直性脊柱炎，银屑病关节炎，中度至重度多关节型幼年特发性关节炎，儿科克罗恩病。（生物谷Bioon.com）
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英文原文：ABBVIE'S HUMIRA® (ADALIMUMAB) RECEIVES U.S. FDA APPROVAL FOR EXTENSION OF POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS INDICATION TO PATIENTS AGES 2 AND OLDER
-- POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS (JIA) OCCURS IN APPROXIMATELY 25 PERCENT OF ALL JIA PATIENTS
-- HUMIRA WAS APPROVED IN THE UNITED STATES IN 2008 FOR MODERATE TO SEVERE POLYARTICULAR JIA IN PATIENTS AGES 4 AND OLDER
-- ADDITIONAL WEIGHT-BASED DOSING FOR 2- TO 4-YEAR-OLDS SERVES THE NEEDS OF THIS YOUNGER PATIENT POPULATION
-- HUMIRA HAS ORPHAN DRUG DESIGNATION FOR THIS PATIENT POPULATION
Oct 6, 2014
NORTH CHICAGO, Ill., Oct. 6, 2014 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved the extension of the HUMIRA indication for moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) to reducing signs and symptoms in patients ages 2 and older. HUMIRA was approved in the United States in 2008 for polyarticular juvenile idiopathic arthritis (JIA) in patients ages 4 and older.
"AbbVie is pleased that children between the ages of 2 and 4 living with polyarticular JIA will now have HUMIRA as an additional treatment option," said Scott Brun, M.D., vice president, Pharmaceutical Development, AbbVie. "This approval represents AbbVie's continued commitment to making HUMIRA available to address the needs of patients living with a wide range of immune-mediated diseases."
JIA is the most common form of childhood arthritis. Polyarticular JIA, which occurs in approximately 25 percent of all JIA patients, is one of seven types of JIA, and involves five or more joints. Symptoms include painful, swollen and tender joints, limping, morning stiffness, decreased activity and the reluctance to use an arm or leg. Early diagnosis and appropriate management of JIA are important in managing this chronic disease.
HUMIRA will be available to patients ages 2 and older living with polyarticular JIA with the dose based on patient weight. HUMIRA is available for this patient population in a 10 mg pre-filled syringe, 20 mg pre-filled syringe, 40 mg pre-filled syringe and 40 mg HUMIRA auto-injector pen.
In the European Union, HUMIRA was approved in 2008 for the treatment of children and adolescents ages 4 to 17 years living with polyarticular juvenile idiopathic arthritis and in 2013 the age range was expanded to patients ages 2 to 17.
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