近日；诺华单抗药物Cosentyx（secukinumab）获得了欧洲药品管理局（EMA）人用医药产品委员会（CHMP）的积极意见。CHMP已建议批准secukinumab作为一线系统性疗法，用于中度至重度斑块型银屑病（plaque psoriasis）成人患者的治疗（相关阅读：诺华公司抗炎症药物secukinumab治疗银屑性关节炎取得重大突破）。在美国，FDA皮肤科和眼科药物顾问委员会（DODAC）于今年10月一致建议批准secukinumab。
欧盟委员会（EC）预计将在2个月内做出最终审查决定。在欧洲，目前所有治疗银屑病的生物制剂（包括抗肿瘤坏死因子疗法（anti-TNFs）及ustekinumab），均被推荐作为二线系统性疗法。此次CHMP的积极意见，意味着医生可以使用secukinumab取代其他具有显著副作用的一线系统疗法，用于银屑病患者的一线治疗。
如果获批，secukinumab将成为市面上首个IL-17阻断剂药物。目前，银屑病市场由TNF阻断剂（抗肿瘤坏死因子单抗）统治，然而有高达40%的患者对TNF阻断剂治疗不足或无反应。而IL-17阻断剂的上市，将极大地改善银屑病、银屑病关节炎及其他炎症性疾病的临床标准护理。
有分析师认为，尽管诺华secukinumab很可能是上市的首个IL-17阻断剂，但该市场将很快迎来其他竞争产品。紧跟secukinumab之后的是安进和阿斯利康开发的类似药物brodalumab，该药在银屑病和银屑病关节炎III期临床中均创下了骄人的成绩。此外，礼来的IL-17阻断剂ixekizumab目前已进入III期临床，默沙东的MK-3222和强生（JNJ）的IL-23阻断剂guselkumab也将于本季度进入III期临床开发。
目前，诺华正在调查secukinumab用于多种炎症疾病的治疗，包括银屑病、银屑病关节炎、强直性脊柱炎（AS）和类风湿性关节炎（RA）。业界预测，如果这4个适应症均获批，secukinumab到2020年的销售额将突破10亿美元。
今年10月，secukinumab在强直性脊柱炎（AS）2个关键III期研究（MEASURE-1，MEASURE-2）获得成功（相关阅读：诺华单抗secukinumab强直性脊柱炎III期临床大获成功），研究中secukinumab显著改善了疾病的症状和体征，同时也显著改善了患者的身体机能和生活质量。该研究成果也标志着secukinumab成为首个在强直性脊柱炎（AS）III期临床获得成功的IL-17A阻断剂。这2项研究中，secukinumab的安全性与该药在银屑病大型III期项目中的安全性一致。诺华已计划在2015年提交secukinumab治疗银屑病关节炎（PsA）和强直性脊柱炎（AS）的监管申请。
New Drugs Online Report for secukinumab
Information
Generic Name: secukinumab
Trade Name: Cosentyx
Synonym: AIN 457C
Entry Type: Licence extension / variation
Development and Regulatory 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 3 |
