2014年6月6日国际新药快讯

EMA授予勃林格殷格翰激酶抑制剂nintedanib加速审批资格

                               
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发布日期：2014-06-06  来源：新药汇
欧洲药品管理局（EMA）接受审查勃林格殷格翰激酶抑制剂nintedanib治疗特发性肺纤维化（IPF）的上市许可申请，并已授予该药MAA加速评估资格。

勃林格殷格翰（Boehringer Ingelheim）6月5日宣布，欧洲药品管理局（EMA）已接受审查口服三联血管激酶抑制剂nintedanib治疗特发性肺纤维化（IPF）的上市许可申请（MAA），同时授予该药MAA加速评估资格。Nintedanib用于IPF治疗的MAA，包括来自2项III期研究（INPULSIS-1和INPULSIS-2）的数据，在这些研究中，nintedanib显著推迟了IPF患者病情的恶化，均达到了研究的主要终点。

此前，勃林格殷格翰于2013年10月也提交了nintedanib治疗非小细胞肺癌（NSCLC）的上市许可申请，该药NSCLC MAA的提交，是基于一项国际性、双盲III期LUME-Lung 1研究的数据，这是在广泛的二线腺癌患者群体所开展的、附加疗法表现出相对于活性对照组具有生存利益的首个试验。该项试验在NSCLC患者中开展，与安慰剂+多西紫杉醇组相比，nintedanib+多西紫杉醇治疗组疾病无进展生存期（PFS）表现出统计学意义的显着延长（3.4个月 vs 2.7个月），肿瘤再度生长风险降低21%，总生存期（OS）显着延长（12.6个月 vs 10.3个月），平均延长20%。
关于Nintedanib：
Nintedanib是一种口服三联血管激酶抑制剂，可同时阻断3种生长因子受体：血管内皮生长因子受体（VEGFR 1-3）、血小板源性生长因子受体（PDGFR α和β）、成纤维细胞生长因子受体（FGFR 1-3）。所有这3种受体在血管生成和肿瘤生长过程中均发挥着重要作用。这些受体的阻断，可能导致血管生成的抑制，而血管生成在肿瘤生长中起着关键作用。
目前，勃林格殷格翰正在多种实体瘤中评价nintedanib，包括晚期非小细胞肺癌、卵巢癌、肝癌（肝细胞癌）、肾癌（肾细胞癌）、大肠癌等。
英文原文：EMA accepts marketing authorisation application for nintedanib* in IPF
Acceptance of marketing authorisation application marks the beginning of the regulatory review process for nintedanib* in IPF in EU
EMA has accepted the request for accelerated assessment
Application for nintedanib* in IPF is supported by pivotal data from two replicate Phase III trials involving more than 1,000 patients
data show that nintedanib* consistently slows disease progression by reducing annual decline in lung function by half
Ingelheim, Germany, 05. June 2014 – Boehringer Ingelheim today announced that the application for marketing authorisation of nintedanib*, a tyrosine kinase inhibitor (TKI), for the treatment of idiopathic pulmonary fibrosis (IPF) has been validated and granted accelerated assessment by the European Medicines Agency (EMA).The acceptance of this marketing authorisation application marks the beginning of the review process in the European unio for this potential new treatment.
“IPF is a relentless and fatal lung disease, and there is a high unmet need for effective treatments that can slow disease progression,” said Professor Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim.  “Acceptance of our marketing authorisation application takes us one step closer to meeting this unmet need and providing a new treatment option to patients living with IPF.”
The marketing authorisation application for nintedanib* included results from two Phase III trials with identical design, INPULSIS™-1 and INPULSIS™-2, which show nintedanib* significantly slowed disease progression in patients with IPF. data from the two 52-week trials, recently published in the New England Journal of Medicine, demonstrate that nintedanib* met the  primary endpoint by significantly reducing the annual decline in forced vital capacity by approximately 50% compared to patients taking placebo.1 This effect on disease progression was further supported in the pooled data set by a positive signal in reducing the risk of acute exacerbations by 38% (p=0.08) and a significant risk reduction in confirmed or suspected acute exacerbations by 68% (p=0.005).
Nintedanib*, two capsules a day, is the first targeted treatment for IPF that has consistently demonstrated to slow disease progression in IPF by significantly reducing the decline in lung function by half with a manageable side effect profile. Boehringer Ingelheim is committed to making nintedanib* available to patients with IPF and is prepared to respond to requests for compassionate use, subject to local regulations.
*Nintedanib is an investigational compound. Its safety and efficacy have not yet been fully established.
about nintedanib*
Nintedanib* is an investigational small molecule tyrosine kinase inhibitor (TKI) in development by Boehringer Ingelheim for idiopathic pulmonary fibrosis (IPF).2 It targets growth factor receptors, which have been shown to be potentially involved in pathomechanisms of pulmonary fibrosis, most importantly the platelet-derived growth factor receptor (PDGFR), fibroblast growth factor receptor (FGFR) and vascular endothelial growth factor receptor (VEGFR).2,3,4 By blocking the signalling pathways that are involved in fibrotic processes, it is believed that nintedanib* has the potential to reduce disease progression in IPF by slowing the decline of lung function.2,3,5 Nintedanib* is also in clinical development as a treatment option for cancer, including non-small cell lung cancer, ovarian cancer, colorectal cancer and hepatocellular carcinoma.
about idiopathic pulmonary fibrosis
Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive, severely debilitating and ultimately lethal lung disease for which there are limited treatment options.6 IPF affects as many as 14–43 people per 100,000 worldwide.7,8 IPF is characterised by progressive scarring of lung tissue and loss of lung function over time.3,9 Development of scarred tissue is called fibrosis.6 Over time, as the tissue thickens and stiffens with scarring, the lungs lose their ability to take in and transfer oxygen into the bloodstream, and vital organs do not get enough oxygen.10 As a result, individuals with IPF experience shortness of breath, cough and often have difficulty participating in everyday physical activities


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艾伯维爱尔兰Sligo API工厂正式建成 为丙肝鸡尾酒疗法上市做好准备

                               
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发布日期：2014-06-06  来源：新药汇
艾伯维在爱尔兰Sligo工厂扩建完成，共投资1.15亿美元，已为丙肝鸡尾酒疗法的上市做好充足准备。该公司在4-5月接连向FDA、欧盟、加拿大提交了丙肝鸡尾酒疗法的监管文件。

                               
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艾伯维（AbbVie）6月3日举行庆典，庆祝爱尔兰Sligo新近扩建工厂的正式建成，爱尔兰总理恩达肯尼出席了庆典仪式。
Sligo API（活性药物成分）工厂扩建工程始于2012年，共投资8500万欧（约合1.15亿美元）。新的生产线将用于准备生产丙肝、肿瘤学和女性健康方面的活性药物成分。
目前，艾伯维正殷切等待欧盟和FDA对其丙肝鸡尾酒疗法的审查结果。今年4月和5月，艾伯维接连向FDA、EMA、加拿大卫生部提交了丙肝鸡尾酒疗法的监管文件，寻求批准用于基因型1（GT1）丙型肝炎病毒（HCV）成人感染者的治疗，包括伴有肝硬化的HCV群体。此前，FDA、欧盟、加拿大均已授予该鸡尾酒疗法优先审查资格。
AbbVie开发的丙肝鸡尾酒疗法是一种全口服、无干扰素方案，由固定剂量ABT-450/ritonavir/ABT-267（150mg/100mg/25mg，每日一次）和ABT-333（250mg，每日2次）有或无利巴韦林（基于体重，每日2次）组成。ABT-450、ABT-267、ABT-333分别具有不同的作用机制，能够中断HCV的复制过程，在不同患者群体中具有优化的持续病毒学应答率。
该丙肝鸡尾酒疗法监管文件的提交，是基于在慢性基因型1（GT1）HCV群体中开展的迄今为止最大的全口服、无干扰素III期临床项目的数据。该项目包括6个III期研究，涉及超过25个国家2300多名患者。
如果获批，艾伯维鸡尾酒疗法将与吉利德科学（Gilead Science）的丙肝药物Sovaldi展开激烈竞争。若艾伯维尝试通过较低的价格抢占市场份额，可能会迫使吉利德降低Sovaldi成本。
Sovaldi，是上市的首个口服丙肝药物，该药自诞生起便成为行业关注的焦点，而其84000美元/疗程（1000美元/片）的定价也饱受争议
Sovaldi于2013年12月获FDA批准，是上市的首个口服丙肝药物，自诞生起便成为行业关注的焦点。Sovaldi在2014年第一季度的销售额达22.7亿美元，一个疗程治疗成本高达8.4万美元（1000美元/片）
英文原文：ABBVIE OPENS EXPANDED MANUFACTURING FACILITY IN SLIGO, IRELAND
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