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CHMP建议批准诺华索雷尔(Xolair)治疗CSU

  1. CSU
  2. omalizumab
  3. Xolair
  4. 慢性自发性荨麻疹
  5. 索雷尔
  6. 诺华

来源:生物谷 2014-01-26 10:16

CHMP建议批准诺华单抗药索雷尔(Xolair),作为一种附加药物,用于慢性自发性荨麻疹(CSU)的治疗。

2014年1月25日讯 /生物谷BIOON/ --诺华(Novartis)1月24日宣布,欧洲药品管理局(EMA)人用医药产品委员会(CHMP)建议批准单抗药Xolair(omalizumab,奥马珠单抗),作为一种附加药物,用于对H1抗组胺药物反应不足的12岁及以上青少年和成人慢性自发性荨麻疹(CSU)患者的治疗。CHMP推荐的剂量为每4周皮下注射300mg。

欧盟委员会(EC)通常会遵循CHMP的建议,并在2个月内做出最终审查决定。

CHMP的积极意见,是基于3项关键性III期注册研究(ASTERIA I、ASTERIA II、GLACIAL)的积极及一致性结果。这些研究涉及近1000名对抗组胺药物不响应的CSU患者,研究结果表明,300mg剂量omalizumab达到了所有的主要终点及预先指定的次要终点,表明omalizumab能够显著改善瘙痒和荨麻疹,包括快速缓解瘙痒,并在许多情况下完全清除症状。在整个III期项目中,300mg剂量omalizumab治疗组,生活质量显著改善。

诺华曾于2013年公布了Xolair治疗CSU的3项关键性注册研究的数据。

目前,Xolair已获4国(埃及、土耳其、危地马拉、萨尔多瓦)批准,用于慢性自发性荨麻疹(CSU)的治疗。同时,有超过20多个国家正在审查Xolair治疗CSU的监管文件,包括美国、加拿大、澳大利亚、瑞士。

CSU又名慢性特发性荨麻疹(CIU),是一种严重的皮肤疾病,特征是皮肤红肿、痒、时而出现荨麻疹。在世界范围内,CSU的患病率为0.5%至1.0%,超过50%的患者对获批剂量的抗组胺药物治疗无反应。

关于Xolair(omalizumab)

omalizumab是一种实验性单克隆抗体,靶向结合免疫球蛋白E(IgE),该药可能通过减少IgE和细胞激活机制的下游效应,来抑制组胺诱导的皮肤反应。

目前,omalizumab已获全球90多个国家批准,以品牌名索雷尔(Xolair)上市,用于治疗中度至重度持续性过敏性哮喘,该药由诺华和罗氏旗下基因泰克(Genentech)合作开发。(生物谷Bioon.com)


英文原文:Novartis reports positive opinion from CHMP for Xolair® in severe form of skin disease CSU, a debilitating form of hives and chronic itch

—CHMP granted a positive opinion for the use of Xolair® (omalizumab) as an add-on therapy for chronic spontaneous urticaria (CSU) in adult and adolescent patients 12 years and above with inadequate response to H1 antihistamines

—Xolair showed consistent high efficacy across three Phase III CSU studies and in many cases completely cleared symptoms with safety comparable to placebo

—Up to 50% of patients do not respond to approved doses of antihistamines[4], currently the only licensed treatment for CSU in the European Union (EU)

—CSU is a persistent, debilitating form of chronic itch, hives and angioedema affecting approximately 0.5-1% of the world's population at any given time

Basel, 24 January, 2014 - Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the use of Xolair® (omalizumab) as an add-on therapy for the treatment of chronic spontaneous urticaria (CSU) in adult and adolescent (12 years and above) patients with inadequate response to H1 antihistamine treatment. The recommended dose is 300 mg by subcutaneous injection every four weeks.

At any given time, the prevalence of chronic urticaria (CU) is up to 1% of the world's population[5], and up to two thirds of these patients have CSU[5],[6]. CSU is also known as chronic idiopathic urticaria (CIU) in the US, and is a severe and distressing skin condition characterized by red, swollen, itchy and sometimes painful hives or wheals on the skin that spontaneously present and re-occur for more than six weeks[3],[7],[8]. Up to 40% of CSU patients also experience angioedema, a swelling in the deep layers of the skin[4].

"This positive news from the CHMP brings us one step closer to providing an innovative therapeutic option from our specialty dermatology portfolio to people suffering from this chronic and debilitating disease," said Tim Wright, Global Head of Development, Novartis Pharmaceuticals. "If approved, Xolair will be the first and only licensed therapy in the EU for up to 50% of CSU patients not responding to approved doses of antihistamines."

The European Commission generally follows the recommendations of the CHMP and usually issues its final decision within two months of the CHMP opinion.

The CHMP opinion was based on positive and consistent results from three pivotal Phase III registration studies (ASTERIA I, ASTERIA II and GLACIAL) that involved nearly 1,000 patients with CSU not responding to antihistamines. Xolair 300 mg met all primary and pre-specified secondary endpoints across these studies, which showed Xolair significantly improved itch and hives, including rapid itch relief, and in many cases completely cleared symptoms[1]-[3]. Quality of life was also significantly improved for patients treated with Xolair 300 mg[1]-[3] across the Phase III study program. Negative effects of CSU on quality of life may include sleep deprivation and psychological comorbidities such as depression and anxiety[5],[9]. In these studies, the incidence and severity of adverse events (AEs) was similar between Xolair and placebo recipients[1]-[3].

Results from the three pivotal registration studies for Xolair in CSU were announced in 2013. Highlights from these studies that were previously reported include:

In the ASTERIA II study, 44% of patients receiving Xolair 300 mg were itch-and hive-free after 12 weeks of treatment (p<0.0001)[3].
In the ASTERIA I study, Xolair-treated patients experienced a rapid reduction in itch and hives as early as Week 1, with the therapeutic benefit sustained over 24 weeks of active treatment (p<0.0001)[1].
In the GLACIAL study, more than half of patients who had failed multiple therapies including H1 antihistamines (at up to four times the approved dose) and H2 antihistamines and/or leukotriene receptor antagonists (LTRAs) had their symptoms eliminated or suppressed with Xolair 300 mg (p<0.001)[2].
Xolair has already been approved for the treatment of CSU in four countries: Egypt, Turkey, Guatemala and El Salvador. Regulatory reviews are currently ongoing in more than 20 countries, including the US, Canada, Australia and Switzerland.

Xolair is being jointly developed by Novartis and Genentech, Inc. for CSU.

About the Pivotal Phase III Xolair CSU Studies
Three pivotal Phase III studies, ASTERIA I, ASTERIA II and GLACIAL, evaluated the efficacy and safety of Xolair in nearly 1,000 CSU patients not responding to antihistamines[1]-[3].

ASTERIA I and ASTERIA II were global, multi-center, randomized double-blind studies that evaluated the efficacy and safety of Xolair compared to placebo. The studies enrolled 323 patients and 318 patients respectively, aged between 12 and 75 with moderate to severe CSU[1],[3]. Patients were randomized to Xolair 75 mg, 150 mg or 300 mg or placebo, given subcutaneously every four weeks[1],[3]. ASTERIA I had a 24-week treatment period, with a 16-week follow-up and ASTERIA II had a 12-week treatment period, with a 16-week follow-up period[1],[3].

GLACIAL was a 40-week, global, multi-center, randomized double-blind study that evaluated the safety and efficacy of Xolair compared to placebo. It involved 335 patients aged between 12 and 75 with moderate to severe CSU despite receiving standard-of-care therapy, consisting of concomitant H1 antihistamine therapy (up to four times the approved dose) and other background medications including H2 antihistamines and/or leukotriene receptor antagonists (LTRAs)[2]. Patients were randomized to Xolair 300 mg or placebo (3:1), given subcutaneously every four weeks for a total period of 24 weeks[2].

About Xolair® (omalizumab)
Xolair is a targeted therapy that binds to immunoglobulin E (IgE). Xolair suppresses histamine-induced skin reactions, probably through its reduction of IgE and downstream effects on cellular activation mechanisms[10]. Research is ongoing to understand the mechanism of action of Xolair in CSU, which could lead to a deeper understanding of how the disease develops[4].

Xolair is currently approved for the treatment of CSU in four countries. It is approved for the treatment of moderate to severe persistent allergic asthma in more than 90 countries, including the US since 2003 and the EU since 2005 and has over 400,000 patient years of exposure. In the EU, it is approved for the treatment of severe persistent allergic asthma in children (aged six and above), adolescents and adults. In addition, a liquid formulation of Xolair in pre-filled syringes has been approved in the EU and launched in most European countries. In the US, Xolair for subcutaneous use in appropriate allergic asthma patients is co-promoted by Novartis Pharmaceuticals Corporation and Genentech, Inc.

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