诺华银屑病单抗药物AIN457 (secukinumab) 临床III期研究效果良好

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朵朵7 发表于 2014-10-13 20:09:19 | 只看该作者回帖奖励

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诺华银屑病单抗药物AIN457 (secukinumab) 临床III期研究效果良好

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发布日期：2014-10-13 来源：pmlive

瑞士诺华10月10日宣布，公司旗下单抗药物AIN457 (secukinumab) 临床III期研究效果良好。该药物的适应症是中至重度斑块状银屑病。

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　　Secukinumab (AIN457)是一款完全人源化的单抗，主要作用于白介素-17A（IL-17A）。研究显示，IL-17A存在于大量的斑块状银屑病部位。

　　诺华公司此次进行的是随机、双盲、多中心、安慰剂对比临床III期试验，共有超过3300位患者参与试验。结果显示，大多数接受secukinumab的患者的银屑病皮损面积和严重程度指数（PASI）在试验结束时能下降90%至100%。

　　研究结果还显示，患者在完成治疗一年之后仍能保持疾病不再复发，而且在接受治疗过程中，患者正常生活质量不会受到影响。

　　诺华称，公司已经在2013年向美国和欧洲药监局提交了AIN457 (secukinumab) 的新药申请。美国食品药品监督管理局将会在本月20日举行审评会议，而欧洲人用医药产品委员会（CHMP）将会在12月提交推荐函。

http://www.pmlive.com/pharma_new ... in_psoriasis_605157

Novartis' secukinumab has 'consistent' activity in psoriasisReinforces data that suggests drug is more effective than Amgen’s Enbrel

Novartis' psoriasis candidate secukinumab can achieve high rates of skin clearance despite the severity of the disease at the start of treatment, according to new data.
The anti-interleukin-17A antibody - also known as AIN457 - healed 90% to 100% of skin lesions in "a majority" of patients after 12 weeks' treatment with a 300mg once-weekly dose, according to the analysis, which was carried out on data from four phase III trials.
The data - which was presented at the European Association of Dermatology and Venereology (EADV) Congress in Amsterdam this week - reinforces earlier studies suggesting that secukinumab was more effective in treating psoriasis than Amgen's TNF antagonist Enbrel (etanercept), one of the most widely-used biologic therapies for the disease.
The new finding is important because psoriasis patients' disease severity at the start of treatment has typically been shown to negatively impact their response to other therapies, according to Novartis.
Psoriasis has a prevalence of around 2% to 3% in the Western world and afflicts more than 125 million people worldwide. In severe cases the disease can be devastating with chronic itching and pain and skin lesions that can make patients self-conscious and anxious.
Just last month, an inquest in the UK heard that psoriasis was a significant contributory factor in the suicide of UK nurse Hollie McEwen, who was affected by the disease in childhood and had seen symptoms re-appear in recent years.
Novartis reported additional analyses at the EADV conference, which clearly showed a significant positive relationship between achieving clear to almost clear skin and psoriasis patients' health-related quality of life. Researchers found that 70% of patients treated with secukinumab experienced clear or almost clear skin with no quality of life impairment after 16 weeks' treatment with the drug.
Secukinumab was submitted for approval in the US and Europe last year and is scheduled for review by an FDA advisory committee on October 20, with the EU's Committee for Medicinal Products for Human Use (CHMP) also due to deliver a verdict before the end of the year.
Analysts at evaluate Pharma have predicted the drug could achieve sales of around $570m by 2018, and will compete in the marketplace with other anti-IL17 drugs including AstraZeneca/Amgen's brodalumab and Lilly's ixekizumab.