球No.1添第8个适应症——FDA批准Humira用于儿科克罗恩病患者

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》（点击）榜首，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7个之多。近日，FDA批准了第8个适应症——克罗恩病儿科患者。与其他同类产品相比，Humira是首个可在家中用药的产品。

艾伯维（AbbVie）近日宣布，FDA已批准Humira（修美乐，通用名：adalimumab，阿达木单抗）用于经常规药物（包括硫唑嘌呤，6-巯基嘌呤，甲氨蝶呤）治疗后病情控制不佳的6岁及以上儿科克罗恩病（Crohn's disease，CD）患者，以减少疾病症状和体征，并实现和维持临床缓解。此前，FDA已授予Humira孤儿药地位。

此次批准，代表着Humira在美国的第8个适应症，同时使Humira成为FDA批准用于克罗恩病儿科群体的首个也是唯一一个可在家中用药的生物药。Humira通过抑制肿瘤坏死因子-α（TNF-α）发挥作用，接受适当的注射训练后，该药可在患者家中注射。

Humira新适应症的获批，是基于III期IMAgINE-1研究的积极数据，该研究在中度至重度活动性CD儿科患者（6-17岁）中开展，评价了2种不同的Humira治疗方案对临床缓解的诱导及维持，该项研究也是迄今为止在这一群体中开展的最大的临床研究。由于尚无治愈的药物，因此，当前儿科CD患者的治疗目标之一是诱导和维持临床缓解。

克罗恩病（CD）是一种严重性慢性炎症性（IBD）肠道疾病（GI），最常发生在小肠的末端及大肠的起始端，该病影响着全球约20万儿童。除了腹痛、体重减轻、腹泻等症状外，该病还可导致儿童生长/青春期延迟。在美国，估计有3.8万例儿童和青少年克罗恩病患者。

2012年，欧盟已批准Humira用于经传统疗法治疗失败或不耐受及有禁忌的6-17岁重度活动性克罗恩病患者。

在美国，Humira获批的其他7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。（生物谷Bioon.com）

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英文原文：AbbVie's HUMIRA Gets U.S. FDA Approval For Treatment Of Pediatric Patients

-- HUMIRA IS NOW INDICATED TO TREAT PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER WITH MODERATELY TO SEVERELY ACTIVE CROHN'S DISEASE WHO HAVE HAD AN INADEQUATE RESPONSE TO CORTICOSTEROIDS OR IMMUNOMODULATORS SUCH AS AZATHIOPRINE, 6-MERCAPTOPURINE, OR METHOTREXATE

-- HUMIRA IS THE FIRST BIOLOGIC APPROVED IN THE U.S. THAT CAN BE ADMINISTERED AT HOME FOR THE TREATMENT OF MODERATELY TO SEVERELY ACTIVE CROHN'S DISEASE IN PEDIATRIC PATIENTS

-- FDA GRANTED HUMIRA ORPHAN DRUG DESIGNATION FOR PEDIATRIC CROHN'S DISEASE

Sep 25, 2014

NORTH CHICAGO, Ill., Sept. 25, 2014 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced today that the U.S. Food and Drug Administration (FDA) has approved HUMIRA® (adalimumab) for reducing signs and symptoms, and achieving and maintaining clinical remission, in pediatric Crohn's disease patients 6 years of age and older when certain other treatments have not worked well enough. This FDA approval represents the eighth indication for HUMIRA in the United States and makes it the first and only biologic treatment approved for use in this patient population that can be administered at home.

"Moderate to severe Crohn's disease is a serious chronic disorder that can impact children and adolescents in significant ways during this important stage of their lives," said Jeffrey S. Hyams, M.D., head, Division of Digestive Diseases, Hepatology and Nutrition, Connecticut Children's Medical Center. "The approval of HUMIRA for this patient population offers a new important treatment option for physicians and their patients that can help address this sometimes debilitating disease."

Crohn's disease is a type of inflammatory bowel disease (IBD) which commonly involves the end of the small intestine and the large intestine.1 Crohn's disease can appear at any age, but it is most often diagnosed in adolescents and young adults between 15 and 35 years of age.2 In the United States, there are an estimated 38,000 children and teens with Crohn's disease.3 Symptoms of pediatric Crohn's disease are similar to those in adults and can include abdominal pain, weight-loss and diarrhea.2 Additionally, when Crohn's disease is diagnosed in childhood, it may be more extensive than when it is diagnosed in adulthood.4 Since there is no known cure for Crohn's disease, one of the treatment goals of pediatric Crohn's disease is to induce and maintain clinical remission.5, 6

"Children living with moderate to severe Crohn's disease have limited treatment options and AbbVie is pleased that HUMIRA will now be an available option for many of these patients," said Michael Severino, M.D., executive vice president, Research and Development and chief scientific officer, AbbVie. "This approval underscores our continued commitment to innovate with HUMIRA, both in studying potential new indications to help meet unmet medical needs and in helping to improve the standard of care for patients living with immune-mediated inflammatory diseases like Crohn's disease."

HUMIRA works by inhibiting tumor necrosis factor-alpha (TNF-α) and can be self-administered after proper injection training is received and with appropriate physician monitoring.

In 2012, the European Commission approved HUMIRA for the treatment of pediatric patients 6 to 17 years of age with severe active Crohn's disease who failed, are intolerant to, or have contraindications to conventional therapy.7

About IMAgINE-1
The FDA approval was supported by the Phase 3 IMAgINE-1 trial, which evaluated multiple dosing strategies of HUMIRA to induce and maintain clinical remission in pediatric patients with moderately to severely active Crohn's disease for whom certain other treatments have not worked well enough. IMAgINE-1 is the largest multi-center, randomized, double-blind anti-TNF trial in patients 6 to 17 years of age with moderately to severely active Crohn's disease conducted to date.