FDA批准奥马珠单抗治疗慢性特发性荨麻疹

美国食品药品管理局(FDA)批准将奥马珠单抗（Xolair）用于年龄≥12岁且在H1-抗组胺药治疗后仍有症状的慢性特发性荨麻疹患者的治疗。

奥马珠单抗最早于2003年获准用于治疗中至重度哮喘。2007年，FDA要求仅限于在医生诊室中使用这种药物，目的是监测潜在重度过敏反应；同时增补了一项加框警告。

该药品的研发者基因泰克公司声称，奥马珠单抗是首个治疗慢性特发性荨麻疹的生物制剂，也是继非镇静H1-抗组胺药之后首个获准用于治疗慢性特发性荨麻疹的药物。

这项批准令是基于两项研究——ASTERIA I和ASTERIA II5研究的结果，这两项研究都是在2013年11月的欧洲皮肤与性病学会年会上公布的。

基因泰克公司称，每时每刻都有大约150万美国人正在发生慢性特发性荨麻疹，女性发生这种疾病的几率为男性的两倍。

慢性特发性荨麻疹“可能是一种治疗非常棘手的疾病”，美国哮喘与过敏基金会高级副总裁Mike Tringale在基因泰克公司发布的一项声明中说。“患者可能数月或数年遭受瘙痒和荨麻疹的折磨，Xolair的新适应证可能为某些患者达到满意的瘙痒和荨麻疹减轻带来了希望。”

奥马珠单抗是由基因泰克和诺华制药公司联合研发的，在美国由这两家公司联合销售。

By: ALICIA AULT, Internal Medicine News Digital Network


The Food and Drug Administration has approved omalizumab (Xolair) for chronic idiopathic urticaria in people 12 years of age and older who remain symptomatic despite treatment with H1-antihistamine therapy

Omalizumab was first approved in 2003 for moderate to severe asthma. In 2007, the FDA required the drug to be administered in a doctor’s office only, to monitor for potentially severe anaphylaxis; a boxed warning was added at that time.

According to the drug’s developer, Genentech, omalizumab is the first biologic and the first medicine approved for chronic idiopathic urticaria since nonsedating H1-antihistamines.

The approval was based on the results from two studies, ASTERIA I and ASTERIA II5, which were presented in November 2013 at the annual congress of the European Academy of Dermatology and Venereology.

According to Genentech, about 1.5 million Americans develop chronic idiopathic urticaria at some point, with women twice as likely as men to get the condition.

Chronic idiopathic urticaria "can be a frustrating condition for patients," said Mike Tringale, senior vice president at the Asthma and Allergy Foundation of America in a statement issued by Genentech. "This new use for Xolair gives hope to appropriate patients who can go for months or even years without getting satisfactory itch and hives reduction."

malizumab was jointly developed by Genentech and Novartis Pharma, and is copromoted in the United States with Novartis.

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学习了！！FDA批准将奥马珠单抗用于年龄≥12岁且在H1-抗组胺药治疗后仍有症状的慢性特发性荨麻疹患者的治疗。