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Cosentyx(secukinumab)白介素-17A抑制剂获欧洲批准

2015-01-26 11:31:54 作者：新特药房来源：互联网浏览次数：352 文字大小：【大】【中】【小】

简介： 新重组单抗Cosentyx (secukinumab) 用于中度至重度牛皮癣(银屑病)患者将成为首个IL-17阻断剂日前，诺华宣布欧盟委员会批准Cosentyx(secukinumab)作为一款一线全身性治疗药物用于全身性治疗候选成人患者中 ...

关键字：依那西普 secukinumab 药品商标名cosentyx 新重组单抗首个IL-17阻断剂用于治疗斑块性银屑病、中度至重度牛皮癣(银悄病)

新重组单抗Cosentyx (secukinumab) 用于中度至重度牛皮癣(银屑病)患者将成为首个IL-17阻断剂
日前，诺华宣布欧盟委员会批准Cosentyx(secukinumab)作为一款一线全身性治疗药物用于全身性治疗候选成人患者中重度斑块状银屑病治疗。该公司指出，这款药物“是在欧洲获得批准的首款也是唯一一款白介素-17A抑制剂，”并补充称Cosentyx提供了一种“重要的一线生物治疗选择。”
诺华药品主管Epstein表示，“几乎有一半的银屑病患者对目前包括生物药物在内的治疗药物不满意，这些药物对患者显示有明显未满足的需求。”该公司指出，目前的银屑病生物治疗药物，包括抗肿瘤坏死因子治疗药物及强生的优特克单抗，在欧洲被推荐用于二线全身性治疗。
此前，欧洲药品管理局人用医药产品委员会给了Cosentyx一个积极推荐，这款药物的获批基于其临床研究，研究显示以该药物300mg剂量治疗的患者中有70%或更多的人在治疗的第一个16周达到皮肤清除或几乎清除，在治疗到53周时这种疗效在大多数人中仍有保持。诺华指出，结果还证明从清除到几乎清除与银屑病患者健康相关生活质量之间有“明显的积极关系”。
该制药商补充称，最近3bCLEAR研究的数据显示，在中重度斑块状银屑病患者皮肤清除方面，Cosentyx优于优特克单抗。此外，在FIXTURE研究中Cosentyx还显示优于安进的依那西普。
Cosentyx之前也被称为AIN457，这款药物去年12月获得其全球第一次批准，日本药品监管机构批准这款药物治疗除生物治剂外对全身性治疗药物没有充分响应的成人患者的寻常性银屑病及银屑病性关节炎。这款药物在澳大利亚还被许可用于中重度斑块状银屑病治疗，而FDA对该药物用于这一适应症的决定有望于2015年初做出，去年一顾问委员会已一致推荐批准这款药物
New Drugs Online Report for secukinumab
Information
Generic Name: secukinumab
Trade Name: Cosentyx
Synonym: AIN 457C
Entry Type: Licence extension
Developmental Status
UK: Phase III Clinical Trials
EU: Phase III Clinical Trials
US: Phase III Clinical Trials
UK launch Plans: Available only to registered users
Actual UK launch date:
Comments
Mar 14: Planned filing 2017 [7]
12/03/2014 10:27:52
March 11: Regulatory filings for non-infectious uveitis planned for 2013 (6)
21/03/2011 14:14:00
Filings planned 2011 (4).
11/06/2010 12:42:33
Trial or other data
Mar 14: The extension study to the INSURE study (NCT01103024) , INSURE (NCT01095250) ENDURE (NCT01032915) have all been terminated. [8]
12/03/2014 10:42:49
April 12: No further trial updates.
20/04/2012 11:00:40
Apr 10: A randomized, double-blind, placebo-controlled, multicentre, dose-ranging PIII 34-week extension to a 28-week core INSURE study (NCT01103024 -) is planned to start in Jul 10 and is expected to complete Oct 11. The purpose of the study is to provide patients completing the core study with an opportunity to receive an additional 22 weeks of continuous treatment with AIN457. The primary outcome is the rate of recurrence in 208 adults with active, non-infectious, intermediate, posterior, or panuveitis [3].
19/04/2010 09:27:27
Apr 10: A PIII 28-week multicentre, randomized, double-masked, placebo controlled, dose-ranging study (NCT01095250, INSURE) started in Apr 10 and is expected to complete Feb 11. The study is investigating the efficacy and safety of AIN457 (300mg every 2 or 4 weeks, or 150mg every 4 weeks) vs placebo in inducing and maintaining uveitis suppression in 208 adults with active, non-infectious, intermediate, posterior or panuveitis requiring immunosuppression. The primary outcome is mean change in vitreous haze grade in the study eye from baseline to 28 weeks or at time of rescue, if earlier [3].
19/04/2010 09:26:41
Mar 10: A PIII 38-week extension (NCT01090310) to the 24-week week ENDURE study for maintaining uveitis suppression when reducing systemic immunosuppression in 232 patients with quiescent, non-infectious intermediate, posterior or panuveitis. The primary endpoint is recurrence defined by either: ≥ 2 step increase in vitreous haze with or without an increase in anterior chamber cell grade or decrease in best corrected visual acuity of ≥ 10 ETDRS letters. The study will start in May 10 and is expected to complete Oct 11 [3].
19/04/2010 09:25:56
NCT01032915 (ENDURE) is a 24 week multi-center, randomized, double-masked, dose-ranging PIII study vs placebo for maintaining uveitis suppression when reducing systemic immunosuppression in patients with quiescent, non-infectious intermediate, posterior or panuveitis. It will start Feb 10 and is planned to enroll 232 patients. The primary outcome is the recurrence of active intermediate, posterior, or panuveitis defined by either: ≥2 step increase in vitreous haze with or without an increase in anterior chamber cell grade or decrease in best corrected visual acuity of ≥ 10 ETDRS letters. Expected completion Jan 11 [3].
19/04/2010 09:24:53
June 2008: Proof-of-concept phase II trial (NCT00685399) to assess the safety and efficacy of intravenously administered AIN 457 in the treatment of noninfectious uveitis. The trial will enrol 65 patients in the US, and was due to be completed in December 2009.(2)
13/04/2010 11:54:46
Evidence Based Evaluations
NHSC http://www.haps.bham.ac.uk/publichealth/horizon/outputs/documents/2010/may-aug/AIN-457_chronic_non-infectious_uveitis.pdf
References
Available only to registered users
Category
BNF Category: Corticosteroids and other anti-inflammatory preparations (11.04)
Pharmacology: Targets interleukin 17-alpha
Epidemiology: non-infectious uveitis affecting the posterior segment of the eye affects 0.3 - 1 people per 10,000 in the EU [5]
Indication: Uveitis
Additional Details:
Method(s) of Administration
Subcutaneous
Company Information
Name: Novartis
US Name: Novartis
NICE Information
Anticipated Commissioning route (England) -
In timetable: -
PbR Awaiting Update