2016年5月27日，美国食品和药品监管局(FDA)批准Zinbryta (daclizumab)为有多发性硬化症(MS)的复发型成年的治疗。Zinbryta是一个长效注射剂，可由患者每月自身给药。
FDA的药品评价和研究中心中神经学产品部主任Billy Dunn，M.D.说：“Zinbryta可能对治疗需要新选择的患者提供一个另外选择。”
MS是一种中枢神经系统慢性，炎性，自身免疫病，它破坏脑和机体其他部分间交流。它是在年轻成年中神经学失能最常见原因和在妇女中比男性更频繁发生。对大多数有MS的人，初始地恶性功能(功能)的发作接着是恢复阶段(缓解)。随时间，恢复可能是不完全，导致功能中进展性下降和增加失能残疾。大多数人在年龄20和40 岁间经受其首次MS症状。
在两项临床试验中显示Zinbryta的有效性。一项试验在1,841例参加者中比较Zinbryta和Avonex，研究共144周。用Zinbryta 患者比服用Avonex患者有较少临床复发。第二项试验比较Zinbryta与安慰剂及包括412例参加者被治疗共52周。在该研究中，接受Zinbryta患者比接受安慰剂有较少复发。
Zinbryta应一般地仅被对两个或更多MS药物有反应不佳的患者中使用因为有严重安全性风险，包括肝损伤和免疫情况。因为这个风险，Zinbryta有一个黑框警告和仅通过一个受限的分发程序在风险评估和减灾战略下可得到。
黑框警告告诉处方者药物可能致严重肝损伤，包括危及生命和致命性事件。健康保健专业人员应在开始Zinbryta前，每个月每剂前，和直至目次剂量后6个月进行血液测试监视患者的肝功能。
该黑框警告还强调Zinbryta治疗的其他重要风险包括免疫情况，例如结肠炎症(非-感染性结肠炎)，皮肤反应，和淋巴结肿大，
另外被强调的警告包括超敏性反应(过敏性反应或血管水肿)，对感染增加风险，和抑郁和/或自杀意念的症状。
在临床试验中接受Zinbryta患者报道与Avonex比较最常见的不良反应包括感冒症状(鼻咽炎)，上呼吸道感染，皮疹，流感，皮炎，喉痛(口咽炎)，湿疹，和淋巴结肿大。接受Zinbryta患者当与安慰剂比较报道的最常见不良反应是抑郁，皮疹，和增加的谷丙转氨酶。
Zinbryta是由麻省剑桥的Biogen Inc.公司制造。
New Drugs Online Report for daclizumab
Information
Generic Name: daclizumab
Trade Name: Zinbryta
Synonym: DAC HYP, Zenapax
Entry Type: New molecular entity
Development and Regulatory status
UK: Recommended for approval (Positive opinion)
EU: Recommended for approval (Positive opinion)
US: Pre-registration (Filed)
UK launch Plans: Available only to registered users
Actual UK launch date:
Comments
Apr 16: EU positive opinion for treating adults with relapsing forms of multiple sclerosis (RMS) [18].
29/04/2016 14:15:50
Apr 15: The FDA has accepted application for the approval of ZINBRYTA™ for relapsing forms of multiple sclerosis. [15]
30/04/2015 09:49:51
Mar 15: Filed in the EU. The filing for Zinbryta is based on the DECIDE and SELECT trials [14].
30/03/2015 15:03:25
Sep 14: Biogen Idec and AbbVie plan to file regulatory applications in 2015 [13].
16/09/2014 11:17:38
May 10: First patient enrolled in the PIII DECIDE study [5].
24/05/2010 21:25:07
PIII trial expected to started 1H 2010 [3].
02/09/2009 08:32:45
PII study for monotherapy planned (1)
Trial or other data
Oct 15: Results of DECIDE, published in NEJM, show that daclizumab was associated with a lower annualised relapse rate than interferon beta-1a (0.22 vs. 0.39, respectively; P<0.001) in patients with relapsing-remitting MS. Infections, cutaneous events and LFT elevations were however more common [16]. Although the annualised relapse rate in this study was lower with daclizumab than interferon beta-1a, there was no statistically significant difference between the two groups in terms of disability progression confirmed at 12 weeks at week 144 (16% and 20%, respectively; P=0.16) [17].
13/10/2015 10:12:12
Sept 14: Results from PIII DECIDE study. Pts taking daclizumab had a statistically significant 45% reduction in annualised relapse rate compared to pts treated with interferon beta-1a (p<0.0001). Daclizumab demonstrated superiority in reducing the number of new or newly enlarging T2-hyperintense lesions at week 96, with a 54% reduction relative to inteferon beta-1a. The risk of three-month confirmed disability progression, as measured by the Expanded Disability St |
