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美国FDA批准Raplixa用于手术时帮助控制出血

2015-05-02 14:54:42 作者：新特药房来源：互联网浏览次数：130 文字大小：【大】【中】【小】

简介： Raplixa第一个被监管局批准的喷雾-密封胶2015年4月30日，美国食品和药品监管局(FDA)批准(纤维蛋白密封胶[人]fibrin sealant [human]),被监管局批准的第一个喷雾密封胶。在手术期间使用有助控制出血。Rapl ...

关键字：纤维蛋白密封胶[人]fibrinsealant[human]商品名raplixa 手术时帮助控制出血第一个喷雾-密封胶

Raplixa第一个被监管局批准的喷雾-密封胶
2015年4月30日，美国食品和药品监管局(FDA)批准(纤维蛋白密封胶[人]fibrin sealant [human]),被监管局批准的第一个喷雾密封胶。在手术期间使用有助控制出血。
Raplixa是一种生物制品批准在成年中使用当标准手术技术，例如缝合，结扎或烧灼，是无效的或不切实际时有助控制来自小血管出血。当应用于一个出血部位，Raplixa被溶解在血中和纤维蛋白和纤溶酶蛋白间开始一种反应。这导致血凝块形成有助停止出血。
Raplixa含纤维蛋白和凝血酶，人血液液体部分血浆中发现的两种蛋白。这两种蛋白组分是各自独立地用某种制造过程被纯化，其中包括病毒灭活和去除步骤有助于减低血源性病毒传播的危险。然后纤维蛋白密封胶组分被喷雾干燥，混合和包装在小瓶。Raplixa可直接地从原始产品小瓶或者用一个输送装置喷雾至出血部位。它已被批准与可吸收的明胶海绵联用。
FDA的生物制品评价和研究中心主任Karen Midthun，M.D.说：“这个批准提供外科医生在需要时的一种另外选择有助于在手术期间控制出血，”“喷雾-干燥过程用于制造生产可以组合成一个单一小瓶的干燥粉。这样消除了需要在使用前的纤维蛋白原和凝血酶结合和允许产品在室温下贮存。”
在支持批准中，FDA审评了一项来自涉及719例参加者，跨越11个月，进行不同类型外科手术临床研究的数据。研究显示Raplixae的有效性通过比较当使用这个纤维蛋白密封胶与单独使用一种可吸收海绵纤维蛋白密封胶，为减少停止出血所需时间。
最常见报道的不良反应是手术疼痛，恶心，便秘，发热和血压减低。
Raplixa是由ProFibrix BV制造，Medicines公司的全资子公司，总部在新泽西Parsippany。
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http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm445247.htm
New Drugs Online Report for fibrinogen + thrombin
Information
Generic Name: fibrinogen + thrombin
Trade Name: Raplixa
Synonym: PRO-0601; Fibrocaps
Entry Type: New formulation
Development and Regulatory status
UK: Approved (Licensed)
EU: Approved (Licensed)
US: Pre-registration (Filed)
UK launch Plans: Available only to registered users
Actual UK launch date:
Comments
Mar 15: The Medicines Company is seeking potential partners to support supply of Raplixa during 2015 and beyond [11].
02/04/2015 09:16:40
Mar 15: Approved in the EU. The marketing authorisation is valid in the 31 countries of the European Economic Area, which includes all 28 EU Member States, plus Norway, Iceland and Liechtenstein [11].
02/04/2015 09:15:44
Jan 15: EU positive opinion for Raplixa as supportive treatment where standard surgical techniques are insufficient for improvement of haemostasis in adults. Raplixa must be used in combination with an approved gelatin sponge [10].
23/01/2015 14:18:51
Oct 14: Trade name changed from Fibrocaps to Raplixa™. [9]
30/10/2014 11:05:31
Apr 14: Filed in the US to aid in haemostasis during surgery, where control of mild or moderate bleeding by conventional means is ineffective or impractical. A decision on approval expected by Jan 31, 2015 [8].
04/04/2014 09:48:28
Nov 13: Filed in the EU. The complementary spray delivery device to assist surgeons in the accurate application of the dry powder Fibrocaps was recently granted a European CE mark. The company plan to file for approval of Fibrocaps in the US in Q1 2014 [7].
22/11/2013 09:21:50
Aug 13: Plan to file in EU Q4 2013 and in US Q1 2014 [6]
07/08/2013 08:22:42
Trial or other data
Oct 14: Positive data from FINISH-3 presented. In this randomised (2:1), single-blind, controlled PIII pivotal trial, pts with mild-moderate surgical bleeding were treated with Raplixa™ (n=480, sprayed on in 50% of cases) or gelatin sponge (n=239) while undergoing spinal (n=183), vascular (n=175), hepatic (n=180), or soft tissue (n=181) procedures. Raplixa™ significantly reduced time to haemostasis (TTH) vs. gelatin sponge; hazard ratios: 3.3, 2.1, 2.3, and 3.4 for the four surgical indications, respectively (each p<0.001; primary endpoint) and significantly reduced median TTH for each indication (p<0.0001). Adverse event incidences were similar between treatment arms. Non-neutralizing, anti-thrombin antibodies developed in 2% and 3% of pts on Raplixa™ vs. gelatin sponge-treated patients respectively. [9]
30/10/2014 11:05:48
Aug 13: The Medicines Company has purchased ProFibrix following the positive results from FINISH-3. The Company believes that Fibrocaps are complementary to Recothrom® ProFibrix also has a proprietary recombinant fibrinogen development program that will potentially allow development of the first recombinant thrombin and recombinant fibrinogen combination products [6].
07/08/2013 09:17:20
Aug 13: Results of the PIII FINISH-3 study reported. The study met all primary and secondary haemostasis efficacy endpoints in four surgical indications of spinal surgery, hepatic resection, soft tissue dissection and vascular surgery. ProFibrix has developed a complementary dry powder spray delivery device to assist surgeons in the accurate application of Fibrocaps. Recently the ProFibrix quality management system for the design, development and control of manufacture of sterile biological haemostat delivery systems and their accessories was granted ISO 14385: 2003 certification. Applications for a European CE mark and for an FDA 510k review for the device are underway [6]
07/08/2013 09:16:38
Jun 13: The Medicines Company will purchase ProFibrix. subject to a satisfactory review of the pending PIII FINISH-3 trial results of ProFibrix´s lead biologic, Fibrocaps. FINISH-3, has completed enrollment of 719 surgical patients with mild to moderate surgical bleeding and results are expected 3Q 2013. If favorable, FINISH-3 is expected to be sufficient to support a filing for marketing approval in the EU and US [5].
05/06/2013 16:10:40
Apr 13: Enrolment completed of PIII FINISH-3 on schedule [4].
05/04/2013 08:39:27
ProFibrix BV is developing Fibrocaps®, a dry powder formulation of fibrinogen & thrombin derived from human plasma, for treatment of acute and severe bleeding associated with elective surgery or trauma. Thrombin is a highly specific protease that transforms fibrinogen into a fibrin clot. Fibrocaps® is formulated using spray drying, which makes small, hollow microspheres of thrombin and fibrinogen. Trehalose carbohydrate is also added during formulation to ensure that the active proteins remain stable and rapidly dissolve in solution. The powder is stored at room temperature and can be applied to the wound without preparation as soon as bleeding starts [3].
13/03/2013 14:50:49
Feb 12: NCT01527357 (Finish-3) A PIII, international randomized, single-blind, controlled trial of topical Fibrocaps™ plus gelatin sponge vs gelatin sponge alone, for achieving hemostasis in 500 subjects with mild to moderate surgical bleeding during spine, liver, vascular or soft tissue surgery. The primary outcome is Time to Hemostasis (TTH) within 5 minutes. The study will start May 12 and is due to complete May 13 [1]. 13/02/2012 09:14:15
07/06/2012 21:43:12
References
Available only to registered users
Category
BNF Category: Antifibrinolytic drugs and haemostatics (02.11)
Pharmacology: Dry powder formulation of fibrinogen and thrombin derived from human plasma
Epidemiology: In cardiac surgery, severe bleeding occurs in approximately 7% of cases; approximately 7% of percutaneous coronary interventions performed emergently in pts with acute coronary syndrome result in major bleeding. Mortality rates approaching 20% have been observed in elective vascular patients with severe bleeding complications [2].
Indication: Haemorrhage
Additional Details: intra-surgical - supportive treatment in adults where standard surgical techniques are insufficient for improvement of haemostasis
Method(s) of Administration
Topical
Company Information
Name: The Medicines Company
US Name: ProFibrix
Further Information
Anticipated commissioning route (England) NHSE
High cost drug list? Yes
Implications Available only to registered users